title: Κανονισμός (ΕΚ) αριθ. 2261/1999 της Επιτροπής, της 26ης Οκτωβρίου 1999, για τροποποίηση των αντιπροσωπευτικών τιμών και των προσθέτων εισαγωγικών δασμών ορισμένων προϊόντων του τομέα της ζάχαρης

eurovoc_concepts:
CCT duties
import
raw sugar
representative price
sugar
white sugar

formats: pdf print

text: 27. 10. 1999 EL Επίσηµη Εφηµερίδα των Ευρωπαϊκών Κοινοτήτων L 276/5 ΚΑΝΟΝΙΣΜΟΣ (ΕΚ) αριθ. 2261/1999 ΤΗΣ ΕΠΙΤΡΟΠΗΣ της 26ης Οκτωβρίου 1999 για τροποποίηση των αντιπροσωπευτικών τιµών και των προσθέτων εισαγωγικών δασµών ορισµένων προϊόντων του τοµέα της ζάχαρης Η ΕΠΙΤΡΟΠΗ ΤΩΝ ΕΥΡΩΠΑΪΚΩΝ ΚΟΙΝΟΤΗΤΩΝ, Έχοντας υπόψη: τη συνθήκη για την ίδρυση της Ευρωπαϊκής Κοινότητας, τον κανονισµό (ΕΟΚ) αριθ. 2038/1999 του Συµβουλίου, της 13ης Σεπτεµβρίου 1999, περί κοινής οργανώσεως της αγοράς στον τοµέα της ζάχαρης (1), τον κανονισµό (ΕΚ) αριθ. 1423/95 της Επιτροπής, της 23ης Ιου- νίου 1995, περί καθορισµού των λεπτοµερειών εφαρµογής για την εισαγωγή προϊόντων του τοµέα της ζάχαρης άλλων από τις µελάσ- σες (2), όπως τροποποιήθηκε τελευταία από τον κανονισµό (ΕΚ) αριθ. 624/98 (3), και ιδίως το άρθρο 1 παράγραφος 2 δεύτερο εδάφιο και το άρθρο 3 παράγραφος 1, Εκτιµώντας: (1) ότι οι αντιπροσωπευτικές τιµές και οι πρόσθετοι εισαγωγικοί δασµοί που εφαρµόζονται στη λευκή ζάχαρη, στην ακατέρ- γαστη ζάχαρη και ορισµένα σιρόπια έχουν καθορισθεί τελευ- ταία από τον κανονισµό (ΕΚ) αριθ. 1441/1999 της Επι- τροπής (4), όπως τροποποιήθηκε από τον κανονισµό (ΕΚ) αριθ. 2203/1999 (5)· (2) ότι, από την εφαρµογή των κανόνων και των λεπτοµερειών καθορισµού που υπενθυµίζονται στον κανονισµό (ΕΚ) αριθ. 1423/95, τα στοιχεία τα οποία διαθέτει, θα πρέπει να τρο- ποποιούν τα ισχύοντα ποσά σύµφωνα µε το παράρτηµα του παρόντος κανονισµού, ΕΞΕ∆ΩΣΕ ΤΟΝ ΠΑΡΟΝΤΑ ΚΑΝΟΝΙΣΜΟ: Άρθρο 1 Οι αντιπροσωπευτικές τιµές και οι πρόσθετοι εισαγωγικοί δασµοί που εφαρµόζονται στα προϊόντα που αναφέρονται στο άρθρο 1 του κανονισµού (ΕΚ) αριθ. 1423/95 καθορίζονται όπως αναγράφεται στο παράρτηµα. Ο παρών κανονισµός αρχίζει να ισχύει στις 27 Οκτωβρίου 1999. Άρθρο 2 Ο παρών κανονισµός είναι δεσµευτικός ως προς όλα τα µέρη του και ισχύει άµεσα σε κάθε κράτος µέλος. Βρυξέλλες, 26 Οκτωβρίου 1999. Για την Επιτροπή Franz FISCHLER Μέλος της Επιτροπής (1) ΕΕ L 252 της 25. 9. 1999, σ. 1. (2) ΕΕ L 141 της 24. 6. 1995, σ. 16. (3) ΕΕ L 85 της 20. 3. 1998, σ. 5. (4) ΕΕ L 166 της 1. 7. 1999, σ. 77. (5) ΕΕ L 268 της 16. 10. 1999, σ. 17. L 276/6 EL Επίσηµη Εφηµερίδα των Ευρωπαϊκών Κοινοτήτων 27. 10. 1999 ΠΑΡΑΡΤΗΜΑ στον κανονισµό της Επιτροπής, της 26ης Οκτωβρίου 1999, για τροποποίηση των αντιπροσωπευτικών τιµών και πρόσθετων δασµών που εφαρµόζονται κατά την εισαγωγή της λευκής ζάχαρης, της ακατέργαστης ζάχαρης, και των προϊόντων του κωδικού ΣΟ 1702 90 99 Κωδικός ΣΟ 1701 11 10 (1) 1701 11 90 (1) 1701 12 10 (1) 1701 12 90 (1) 1701 91 00 (2) 1701 99 10 (2) 1701 99 90 (2) 1702 90 99 (3) Αντιπροσωπευτική τιµή ανά 100 χιλιόγραµµα καθαρού βάρους του εν λόγω προϊόντος Πρόσθετος δασµός ανά 100 χιλιόγραµµα καθαρού βάρους του εν λόγω προϊόντος (σε EUR) 17,25 17,25 17,25 17,25 14,91 14,91 14,91 0,15 7,68 13,87 7,49 13,35 20,22 14,52 14,52 0,49 (1) Καθορισµός για τον αντιπροσωπευτικό ποιοτικό τύπο όπως ορίζεται στο άρθρο 1 του κανονισµού (ΕΟΚ) αριθ. 431/68 του Συµβουλίου (ΕΕ L 89 της 10. 4. 1968, σ. 3) όπως τροποποιήθηκε. (2) Καθορισµός για τον αντιπροσωπευτικό ποιοτικό τύπο όπως ορίζεται στο άρθρο 1 του κανονισµού (ΕΟΚ) αριθ. 793/72 του Συµβουλίου (ΕΕ L 94 της 21. 4. 1972, σ. 1). (3) Καθορισµός ανά 1 % της περιεκτικότητας σε σακχαρόζη


title: 1999/836/EC: Commission Decision of 26 October 1999 on the national provisions concerning mineral wool notified by Germany derogating from Directive 97/69/EC adapting to technical progress for the 23rd time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (notified under document number C(1999) 3490) (Text with EEA relevance) (Only the German text is authentic)

eurovoc_concepts:
Germany
dangerous substance
labelling
national law
packaging
wool

formats: html pdf print

text: L 329/100 EN Official Journal of the European Communities 22. 12. 1999 COMMISSION DECISION of 26 October 1999 on the national provisions concerning mineral wool notified by Germany derogating from Directive 97/69/EC adapting to technical progress for the 23rd time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (notified under document number C(1999) 3490) (Only the German text is authentic) (Text with EEA relevance) (1999/836/EC) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, and in particular Article 95(6) thereof, classification, packaging and labelling of dangerous substances (3) was adopted on 5 December 1997. The latest date for Member States to comply with this was 16 December 1998. the 23rd adaptation Inter alia, introduced: Whereas: I. THE FACTS 1. Community legislation and the Council (2), substances (1) Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), as last amended by Directive 1999/33/EC of the European list of a Parliament dangerous harmonised classification and labelling that apply to such substances. All manufacturers, importers or distributors are required to use the harmonised classification and labelling when placing a dangerous substance on the Community market. The list is regularly updated to take account of the and technical knowledge. This is done by revising specific entries in the list and by adding new entries to the list. contains the in scientific continuous displaying increase list The foreword to Annex I describes particular aspects of the the interpretation of notes that may be added to specific entries. The foreword is also updated when necessary. substances dangerous such of as (cid:151) a general entry on mineral wool dangerous substances in Annex I, into the list of (cid:151) a specific Note Q relating to mineral wool into the foreword to Annex I. The draft for the 23rd adaptation was discussed for more than seven years among the Commission, Member State experts such as the Commission Working Group on Classification and Labelling (cid:151) Health Effects, and experts from the industry involved. The results of these in-depth discussions were taken into account when drafting the draft. Member States delivered a favourable opinion when voting on the draft, with the exception of Germany who voted against. (3) The general entry on mineral wool defines mineral wool as consisting of man-made vitreous (silicate) fibres with random orientation with an alkaline oxide and an alkaline earth oxide content greater than 18 % by weight. All mineral wools are classified as: (cid:151) carcinogenic, category 3, irritant; symbol Xi, R 38, risk phrase R 40; and Updates of Annex I are adopted by adaptations to technical progress in accordance with Article 28 of Directive 67/548/EEC. (cid:151) or labelled with the symbol Xn, R 38-40, safety phrases S (2-)36/37. (2) Commission Directive 97/69/EC of 5 December 1997 adapting to technical progress for the 23rd time Directive laws, 67/548/EEC on regulations and administrative provisions relating to the approximation the the of An exception to this general entry would be a specific wool which was given an individual entry in Annex I. The general entry exempts any such possible individual entries by using the descriptor (cid:145)with the exception of those specified elsewhere in this Annex(cid:146). (1) OJ 196, 16. 8. 1967, p. 1. (2) OJ L 199, 30. 7. 1999, p. 57. (3) OJ L 343, 13. 12. 1997, p. 19. 22. 12. 1999 EN Official Journal of the European Communities L 329/101 Directive 97/69/EC further provides for the addition of a Note Q to the foreword to Annex I. According to Note Q, the classification of a specific mineral wool as carcinogenic, category 3, need not apply if the result of an animal test with the wool is (cid:145)negative(cid:146). Note Q offers the option of four such tests. If a mineral wool were to meet this requirement it would not have to be labelled as carcinogenic. However, the classification and labelling as (cid:145)irritant(cid:146) would remain. ANNEX CAS No EC No No 650-016-00-2 Note A Note Q1 Note R Mineral wool, unless specified elsewhere in this Annex: 2. National provisions (4) The national provisions at issue consist of a proposal by Germany that the Note Q referred to in Article 1(1)(c) of Directive 97/69/EC, and the classification of mineral wools set out in the Annex to that Directive, should be incorporated into its national laws, amending these as follows (see item I in that request): (cid:145)Note Q1: The classification as category 2, carcinogenic, need not apply if it can be established that the substance meets one of the following conditions: (cid:151) an appropriate test involving intraperitoneal injection of a dose of 1 (cid:215) 109 WHO fibres, in the size distribution of a typical workplace has shown no evidence of excess carcinogenicity, (cid:151) the chemical composition of the substances is such that the algebraic sum of the percentages of weight of the oxides Na2O + K2O + CaO + MgO + BaO + B2O3 ﬂ 2Al2O3 is greater than 30. Note Q2: The classification as a category 3 carcinogen need not apply if it can be shown that the substance fulfils one of the following conditions: (cid:151) an appropriate intraperitoneal test at a dose of 5 (cid:215) 109 WHO fibres, in the size distribution of a typical excess workplace, has carcinogenicity, shown no evidence of (cid:151) the half life after intra-tracheal instillation of 2 mg of a fine suspension for fibres with a length of 5 (cid:181)m, a diameter of less than 3 (cid:181)m and a length-to-diameter ratio of more than 3:1 (WHO fibres) is not more than 40 days, or (cid:151) the chemical composition of the substance is such that the algebraic sum of the percentages of weight of the oxides Na2O + K2O + CaO + MgO + BaO + B2O3 ﬂ 2Al2O3 is greater than 40. vitreous [Man-made random (silicate) orientation and an alkaline oxide and an alkaline earth (Na2O + K2O + CaO + MgO + BaO) oxide content greater than 18 % by weight] fibres with Classification Carc. Cat 2; R 49 Labelling T R: 49 S: 53/45 CAS No EC No No 650-016-00-2 Note A Note Q2 Note R Mineral wool, unless otherwise specified in this Annex: vitreous [Man-made random (silicate) orientation and an alkaline oxide and an alkaline earth (Na2O + K2O + CaO + MgO + BaO) oxide content greater than 18 % by weight] fibres with Classification Carc. Cat 3; R 40 Labelling Xn R: 40 S: (2-)22(cid:146) 3. Comparing the national provisions with Community legislation (5) The communication from Germany is in line with Directive 97/69/EC in that mineral wool consists of man-made random (silicate) orientation and an alkaline oxide and alkaline earth oxide content greater than 18 % by weight. fibres with vitreous L 329/102 EN Official Journal of the European Communities 22. 12. 1999 the communication considers However, that mineral wools need to be divided into two categories. The first of these should be: the protection of the working environment(cid:146) (see Item II of the request and the amplifications therein). (cid:151) classified as carcinogenic, category 2, R 49, and be (cid:151) labelled with symbol T, R 49, S 53-45. Inter alia Note Q1 should exempt these mineral wools from the classification as carcinogenic, category 2 on condition that either: (cid:151) the result of an animal test has been (cid:145)negative(cid:146), or (cid:151) the carcinogenicity index (cid:145)KI(cid:146) which is a number calculated from the chemical composition of the wool, exceeds 30. the Office of On 17 December 1998, the Permanent Representative of the Federal Republic of Germany to the European Communities the sent Secretariat-General of the European Commission in an official letter that was received on 21 December 1998. request that to (7) The German request was passed on to the other Member States for comment. No comment was received from the Member States with regard to the content of the notification transmitted to them. III. ASSESSMENT lt can be assumed that such wools should then be classified as carcinogenic, category 3. 1. Rules applying The second category of mineral wools should be (cid:151) classified as carcinogenic, category 3, R 40, and be (cid:151) labelled with symbol Xn, R 40, S (2-)22. Inter alia Note Q2 should exempt these mineral wools from the classification as carcinogenic, category 3 on condition that either: (cid:151) the result of an animal test has been (cid:145)negative(cid:146) and the communication offers the option of two such tests, or (cid:151) the KI exceeds 40. Such wools should then not be classified and labelled at all, not even as irritant, R 38. II. PROCEDURE (9) (6) On 11 December 1998, the Office of the Permanent Representative of the Federal Republic of Germany to the European Communities informed the Secretariat-General of the European Commission, by fax, of a request based on former Article 100a(4) of the Treaty establishing the European Community that the Commission should confirm the proposal made by the Federal Government to incorporate the Note Q referred to in Article 1(1)(c) of Directive 97/69/EC and the classification of mineral wool in the Annex to that Directive into its national laws in an amended form (see above). Germany feels the intended national provisions are justified by (cid:145)the major requirements referred to in Article 36, namely the protection of health and of human and animal lives, and that former Article 100a of (8) The Treaty of Amsterdam has substantially amended the provisions of the Treaty establishing the European Community by replacing paragraphs 3, 4 and 5 of that Article with eight new paragraphs the renumbering of all of the Articles the amended Article has now become Article 95 of the Treaty establishing the European Community. 10. Owing numbered to to 3 The Treaty of Amsterdam does not contain any specific transitional provisions on the rules applying to the earlier notifications concerning the time of entry into force of this Treaty, such as the German notification, which is the subject of this Decision. In the absence of specific provisions extending their scope, the former provisions of Article 100a(4) of the EC Treaty are to be regarded as repealed from the date of entry into force of the new provisions (1 May 1999). Instead the new provisions of the Treaty apply to the examination of this notification with immediate effect from that date. intending to introduce It emerges from Germany’s notification that this is aimed at approval by the Commission of provisions which Germany is after Directive 97/69/EC has been adopted. However, those provisions are not compatible with that Directive. The Commission should therefore examine that notification in the light of Article 95(5) EC that apply if this were the case. Moreover, the Commission must, where appropriate, carry out the checks provided for by Article 95(6) EC. The provisions of Article 95(4) EC cannot be applied in this instance since they solely relate to a situation where a Member State wishes to receive approval to maintain national the already harmonisation measure concerned has been adopted, this not being the case in this instance. provisions adopted before 22. 12. 1999 EN Official Journal of the European Communities L 329/103 (10) It must be stressed that, on the date Germany sent its notification, the Treaty rules applying did not make any provision that this notification had to be based on new scientific proof the environment or workplace because a specific problem in that Member State had arisen after the harmonisation measure had been adopted. This notification must be examined in the light of that specific situation. relating to the protection of 2. Conditions attached to acceptability (11) The notification of Germany is intended to obtain an authorisation to introduce national provisions that are incompatible with Commission Directive 97/69/EC. That Directive constitutes one of the harmonisation measures referred to in Article 95(5) EC, the scope of which deliberately includes harmonisation measures that have been adopted by the Commission. As required by Article 95(5) EC, Germany notified the Commission of the actual wording of the provisions that they were intending to introduce, accompanying their request by an explanation of the reasons which, they felt, justified the introduction of those provisions. the above, the Commission feels that In view of the notification prepared by Germany in order to obtain approval for the introduction of national provisions that were incompatible with Directive 97/69/EC, on the basis of the provisions of former Article l00a(4) of the EC Treaty, can be acceptable pursuant to Article 95(5) EC. 3. Assessment of merits (12) from Article 95 of the It emerges Commission must satisfy itself that all of the conditions enabling a Member State to avail itself of the scope for divergence offered by that Article are met. the Treaty that therefore assess whether The Commission must the conditions provided for by Article 95(5) EC are met. This requires (a) (cid:145)new scientific proof with regard to the protection of the environment and workplace(cid:146), (b) which the causes introduction of national provisions to be necessary (cid:145)as a result of a problem that is specific to that Member State(cid:146), (c) where the the problem concerned arose harmonisation measure had been adopted(cid:146). the applicant Member State to consider (cid:145)after the introduction of such national provisions In addition, pursuant to Article 95(6) EC, where it feels is that those justified the Commission must check whether national provisions are, or are not a means of arbitrary discrimination or a hidden restriction of trade between the Member States and whether they do, or do not, constitute (cid:145)an impediment the internal market(cid:146). to the functioning of 3. 1 New scientific evidence concerning the protection of the environment or workplace following a specific problem in the Member State concerned arising after the harmonisation measure has been adopted (13) Germany is basing its request on the (cid:145)major requirements referred to in Article 36, namely the protection of health and of human and animal life, and the protection of the workplace(cid:146). The national provisions that Germany intends to apply to the classification and labelling of mineral wool are in conformity with Directive 97/69/EC with regard to the such a wool must have. chemical composition that Furthermore, those provisions are in conformity with Notes A and R, which are attached to the classification of mineral wool both in the German provisions and in Directive 97/69/EC. However, the German draft provisions provide for two classes of mineral wool which, with reference to carcinogenicity, are classified as category 2 (stronger carcinogen) and category 3 (weaker carcinogen), whereas Directive 97/69/EC only classifies mineral wool in category 3. It is therefore not possible to evaluate the criteria for exemption from category 2 in the notification from Germany as compared with the exemption criteria in Directive 97/69/EC. For mineral wool classified as (cid:145)category 3, carcinogenic(cid:146) the German notification places the exemption criteria in a Note Q2, whereas Directive 97/69/EC places such criteria in Note Q. The first exemption criterion in Note Q2 gives more details concerning an intra-peritoneal test than Note Q in an Directive test(cid:146). The criteria in both (cid:145)appropriate intra-peritoneal notes could be considered as equivalent, at in certain cases. 97/69/EC, which requires simply least the intra-tracheal The second criterion in Note Q2 describes a test with intra-tracheal instillation in detail. Again, the description of in Note Q in Directive 97/69/EC is less detailed. A notable difference is, however, that Note Q2 also includes relatively short mineral wool fibres, whereas Note Q in Directive 97/69/EC concentrates on longer fibres. instillation test L 329/104 EN Official Journal of the European Communities 22. 12. 1999 (CI) The third criterion in Note Q2 refers to the chemical composition of a wool required for exemption from the classification as carcinogenic. This is an application of index which, according to the opinion (4) the KI adopted by the Scientific Committee for Toxicology, Ecotoxicology and the Environment (CSTEE) by written (cid:145)not been procedure on 10 September 1999, has extensively chemical the to composition of a fibre is informative with regard to its carcinogenicity(cid:146). There is no equivalent to the KI (CI) index in Note Q in Directive 97/69/EC. confirm that tested considered to contain any evidence that has not previously been considered by the Commission and other Member the in the meetings development and adoption of Directive 97/69/EC(cid:146). leading States to Thus, with regard to the scientific arguments presented by Germany, the situation is the same as before the adoption of Directive 97/69/EC. These arguments had not convinced the experts from the other Member States during the preparatory scientific discussions. Finally, Note Q in Directive 97/69/EC also lists a short-term biopersistence test by inhalation and a long term inhalation test as criteria for exempting mineral wool from classification as carcinogenic. Neither of these two tests is referred to in Note Q2 in the notification from the German authorities. It can therefore be concluded that the scientific/technical arguments put forward in the German notification cannot be considered a better basis for the classification of mineral wool in Directive 97/69/EC. than the provisions that follows the criteria for This being the case it from the classification as a exempting mineral wool carcinogen proposed in the German notification differ to a considerable extent from the criteria laid down in Directive 97/69/EC. One of the proposed criteria, namely the use of the chemical composition has, in the opinion of the CSTEE, not been extensively tested and therefore does not appear to be acceptable. (14) In order to address the scientific/technical reasons put forward in the notification from Germany for applying national provisions which diverge from the requirements of Directive 97/69/EC, the Commission called on experts in the field of classification and labelling to draw up a technical report. In short the arguments from Germany can be summarised as: (cid:151) the classification of mineral wool as laid down in Directive 97/69/EC conflicts with the provisions of Directive 67/548/EEC and is not toxicologically sound, (cid:151) the exemption criteria in Note Q in Directive 97/69/EC contradict scientific knowledge, (cid:151) the planned national provisions tie in with the principles laid down at Community level for avoiding unnecessary animal experiments. (15) to whether The technical report was forwarded to the CSTEE for assessment as it correctly addressed the reasons put forward in the notification from Germany. In its opinion of 10 September 1999 the CSTEE considered in a general comment (cid:145)A scientific evaluation of either document (the German communication and the technical lack of references to the scientific literature. The text of both report) documents mixes allusions and to their potential normative consequences, without drawing a clear distinction between the two(cid:146). is made difficult by the (particularly that of the technical to scientific findings report) that Furthermore, in evaluating the scientific basis for the classification of mineral wool the CSTEE opinion refers, among other to scientific findings that were dismissed in both the notification from Germany and also the technical report. things, Thus, the scientific arguments in the German notification are considered incomplete and cannot serve as a sound basis for the classification of mineral wool. Similarly the It can technical therefore be concluded that the scientific developments in the field of man-made mineral fibres need further evaluation. is of unsatisfactory quality. report In addition, in the light of the requirements laid down in Article 95(5) the Commission asked the CSTEE whether the its communication: by Germany forward reasons put in The technical report refuted each individual argument presented. This included reference to the year long, in depth scientific/technical discussions that had taken place (cid:145)The during the preparation of Directive 97/69/EC: is not Communication from the Federal Government (a) represented or contained new scientific evidence which had arisen after 5 December 1997 (the date of adoption of Directive 97/69/EC); (4) http://europa. eu. int/comm/dg24/health/sc/sct/out48_en. html workplace; (b) related to the protection of the environment or the 22. 12. 1999 EN Official Journal of the European Communities L 329/105 (c) constituted a justification based on a problem which was specific to the Federal Republic of Germany. constitute an impairment of internal market(cid:146). the functioning of the The CSTEE included its response in its abovementioned opinion of 10 September 1999. (a) with regard to the first requirement of Article 95(5) mentioned above, the opinion of the CSTEE was that the reasons put forward in the notification from the German authorities did not specifically allude to any scientific evidence which had arisen after 5 December 1997. (17) Since the request made by Germany is not justified in the light of the basic conditions set out in Article 95(5) (see the Commission is not obliged to check point 3. 1), whether the national provisions referred to are, or are not, a means of arbitrary discrimination or a hidden barrier to trade between Member States and if they either do or do not constitute an impairment of the functioning of the internal market. the The Commission requirement concerning new scientific evidence in Article 95(5) is not fulfilled. considers therefore that (b) With regard to the second requirement of Article 95(5) mentioned above, the opinion of the CSTEE stated that evidence provided by Germany did indeed relate to the protection of the workplace. scientific the Consequently, 95(5) can be considered as fulfilled. the second requirement of Article (c) With regard to the third requirement of Article 95(5) mentioned above, the opinion of the CSTEE was that the problem of protecting the workplace which Germany intend to tackle with its notification is not specific to Germany. The Commission therefore considers that the third requirement of Article 95(5) is likewise not fulfilled. In view of the opinion of the CSTEE, the Commission feels that the basic conditions set out in Article 95(5) are not met in this particular instance. 3. 2. Arbitrary means of discrimination/hidden restriction of trade between the Member States/impairment of the functioning of the internal market (16) Under Article 95(6), the Commission will either approve or reject any given national provisions (cid:145)after having checked whether these are or are not a means of arbitrary discrimination or a hidden barrier to trade between Member States and if they either do or do not IV. CONCLUSION (18) In view of the above factors, the Commission feels that the request made by Germany: (cid:151) is acceptable, (cid:151) but is not justified. The Commission therefore concludes by rejecting that request in accordance with Article 95(6) of the Treaty, HAS ADOPTED THIS DECISION: Article 1 The national provisions concerning mineral wool, of which the Commission was notified by Germany by fax on 11 December and by a letter dated 17 December 1998, and which diverge from Directive 97/69/EC are hereby rejected. Article 2 This Decision is addressed to the Federal Republic of Germany. Done at Brussels, 26 October 1999. For the Commission Margot WALLSTR(cid:214)M Member of the Commission


title: Instemming nr. 4/99 door de Raad verleend krachtens artikel 55, lid 2, onder c), van het Verdrag tot oprichting van de Europese Gemeenschap voor Kolen en Staal

eurovoc_concepts:
ECSC
applied research
coal
financial aid

text: 16. 11. 1999 NL Publicatieblad van de Europese Gemeenschappen C 327/5 II (Voorbereidende besluiten) RAAD INSTEMMING Nr. 4/99 door de Raad verleend krachtens artikel 55, lid 2, onder c), van het Verdrag tot oprichting van de Europese Gemeenschap voor Kolen en Staal (1999/C 327/05) Bij brief van 8 september 1999 heeft de Commissie de Raad om instemming verzocht, krachtens artikel 55, lid 2, onder c), van het Verdrag tot oprichting van de Europese Gemeenschap voor Kolen en Staal, met de toekenning van financiºle steun aan projecten inzake technisch onderzoek op het gebied van steenkool. In zijn zitting van 26 oktober 1999 heeft de Raad de gevraagde instemming verleend. Voor de Raad De voorzitter K. HEMIL˜


title: Verordening (EG) nr. 2260/1999 van de Commissie van 26 oktober 1999 tot verlaging van de steun voor te verwerken sinaasappelen voor het verkoopseizoen 1999/2000 in verband met de overschrijding van de verwerkingsdrempel

eurovoc_concepts:
agro-industry
aid system
citrus fruit
production aid

text: L 276/4 NL Publicatieblad van de Europese Gemeenschappen 27. 10. 1999 VERORDENING (EG) Nr. 2260/1999 VAN DE COMMISSIE van 26 oktober 1999 tot verlaging van de steun voor te verwerken sinaasappelen voor het verkoopseizoen 1999/2000 in verband met de overschrĳding van de verwerkingsdrempel DE COMMISSIE VAN DE EUROPESE GEMEENSCHAPPEN, Gelet op het Verdrag tot oprichting van de Europese Gemeen- schap, Gelet op Verordening (EG) nr. 2202/96 van de Raad van 28 oktober 1996 tot invoering van een steunregeling voor telers van bepaalde citrussoorten (1), gewĳzigd bĳ Verordening (EG) nr. 858/1999 (2), en met name op artikel 6, Overwegende hetgeen volgt: (1) (2) Bĳ artikel 5, lid 1, van Verordening (EG) nr. 2202/96 is een verwerkingsdrempel voor sinaasappelen vastgesteld die gelĳk is aan 1 189 000 ton. In lid 2 van datzelfde artikel 5 is bepaald dat voor elk verkoopseizoen de overschrĳding van de drempel wordt beoordeeld op basis van het gemiddelde van de in de laatste drie verkoopseizoenen vóór het betrokken verkoopseizoen of in een daarmee overeenkomende periode met steun verwerkte hoeveelheden. Wanneer een overschrĳding is geconstateerd, wordt de steun die voor het betrokken verkoopseizoen is vastgesteld in de bĳlage bĳ de genoemde verordening, verlaagd met 1 % per overschrĳ- dingstranche van 11 890 ton. De lidstaten hebben de met steun verwerkte hoeveel- heden sinaasappelen meegedeeld in het kader van artikel 22, lid 1, onder b), van Verordening (EG) nr. 1169/97 van de Commissie van 26 juni 1997 houdende uitvoe- ringsbepalingen van Verordening (EG) nr. 2202/96 van de Raad tot invoering van een steunregeling voor telers van bepaalde citrussoorten (3), laatstelĳk gewĳzigd bĳ Verordening (EG) nr. 1082/1999 (4). Blĳkens deze gege- vens is de verwerkingsdrempel met 359 838 ton over- schreden. Bĳgevolg moeten de in de bĳlage bĳ Verorde- ning (EG) nr. 2202/96 vastgestelde steunbedragen voor sinaasappelen voor het verkoopseizoen 1999/2000 met 30 % worden verlaagd. (3) De in deze verordening vervatte maatregelen zĳn in overeenstemming met het advies van het Comité van beheer voor verse groenten en fruit, HEEFT DE VOLGENDE VERORDENING VASTGESTELD: Artikel 1 Voor het verkoopseizoen 1999/2000 worden de steunbedragen voor sinaasappelen die voor verwerking worden geleverd, over- eenkomstig artikel 5, lid 2, van Verordening (EG) nr. 2202/96 vastgesteld op: — meerjarencontracten: — seizoenscontracten: — individuele telers: 8,00 EUR/100 kg, 6,96 EUR/100 kg, 6,27 EUR/100 kg. Artikel 2 Deze verordening treedt in werking op de derde dag volgende op die van haar bekendmaking in het Publicatieblad van de Europese Gemeenschappen. Deze verordening is verbindend in al haar onderdelen en is rechtstreeks toepasselĳk in elke lidstaat. Gedaan te Brussel, 26 oktober 1999. Voor de Commissie Franz FISCHLER Lid van de Commissie (1) PB L 297 van 21. 11. 1996, blz. 49. (2) PB L 108 van 27. 4. 1999, blz. 8. (3) PB L 169 van 27. 6. 1997, blz. 15. (4) PB L 131 van 27. 5. 1999, blz. 24


title: 1999/830/EC: Commission Decision of 26 October 1999 on the national provisions notified by the Kingdom of Denmark concerning the use of sulphites, nitrites and nitrates in foodstuffs (notified under document number C(1999) 3416) (Text with EEA relevance) (Only the Danish text is authentic

eurovoc_concepts:
Denmark
chemical salt
foodstuff
foodstuffs legislation
national law
public health

text: 22. 12. 1999 EN Official Journal of the European Communities L 329/1 II (Acts whose publication is not obligatory) COMMISSION COMMISSION DECISION of 26 October 1999 on the national provisions notified by the Kingdom of Denmark concerning the use of sulphites, nitrites and nitrates in foodstuffs (notified under document number C(1999) 3416) (Only the Danish text is authentic) (Text with EEA relevance) (1999/830/EC) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, and in particular Article 95(6) thereof, Whereas: THE FACTS 1. Community legislation (1) Council Directive 89/107/EEC on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption was adopted on 21 December 1988 (1). Article 3(2) of this Directive provides that the Council shall, acting on a proposal from the Commission under the procedure laid down in former Article 100a of the EC Treaty, adopt a list of additives the use of which is authorised to the exclusion of all others and the list of foodstuffs to which these additives may be added, the conditions under which they may be added and, where appropriate, a limit on the technological purpose of their use. (2) Pursuant to the the Commission above provision, presented three proposals for specific directives, the first on sweeteners, the second on colours and the third on (1) OJ L 40, 11. 2. 1989, p. 27. Directive 89/107/EEC as last amended by Directive 94/34/EC (OJ L 237, 10. 9. 1994, p. 1). than colours and sweeteners. These additives other proposals were prepared in accordance with the requirements of Article 6 of Directive 89/107/EEC after consultation with the Scientific Committee for Food (SCF) which had been asked earlier by the Commission to evaluate the safety of additives. The opinions of the SCF, on which the Commission based its proposals for constantly taken into consideration directives, were throughout the discussions on these proposals in the European Parliament and the Council, right up to the themselves. Three specific adoption of directives comprehensive directive referred to in Article 3 of Directive 89/107/EEC were thus adopted (2). Only the third of these three Directives is concerned with this Decision, i. e. European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other and sweeteners. the directives constituting stages than colours in the 2. National provisions (3) Before the entry into force of Directive 95/2/EC, the Danish legislation consisted of a positive list drawn up in October 1988 determining the conditions of use in including nitrates, nitrites and foodstuffs of additives, sulphites, and Order No 242 of 17 April 1991. Member States were required to bring into force the laws, regulations and administrative provisions necessary to (2) Directive 94/35/EC on sweeteners (OJ L 237, 10. 9. 1994, p. 3). Directive 94/35/EC as last amended by Directive 96/83/EC (OJ L 48, 19. 2. 1997, p. 16). Directive 94/36/EC on colours (OJ L 237, 10. 9. 1994, p. 13). Directive 95/2/EC (OJ L 61, 18. 3. 1995, p. 1). Directive 95/2/EC as last amended by Directive 98/72/EC (OJ L 295, 4. 11. 1998, p. 18). L 329/2 EN Official Journal of the European Communities 22. 12. 1999 conditions of use of additives comply with the directive before 25 September 1996. Directive 95/2/EC was transposed in Denmark by Order No 1055 of 18 December 1995 (3). This Order of 18 December 1995 was supplemented by a positive list (4) determining the in the Danish foodstuffs. By letter of 15 July 1996, Government forwarded to the Commission a copy of these national measures transposing Directive 95/2/EC, these measures did not pointing out, however, that concern sulphites, nitrites and nitrates and that it intended, with regard to those additives, to enact national provisions 95/2/EC in accordance with Article 100a(4) of the EC Treaty. On 23 September 1996, namely two days before the time limit for transposing Directive 95/2/EC, Order No 834 was adopted, supplementing the previous Order No 1055 and the positive list as concerned specifically sulphites, nitrites and nitrates (5). from Directive derogating 3. Sulphites caused deterioration them against additives belonging (4) Directive 95/2/EC on food additives other than colours and sweeteners determines the conditions of use of a to several certain number of categories such as preservatives and antioxidants. Article 1(3) of Directive 95/2/EC defines preservatives as (cid:145)substances which prolong the shelf-life of foodstuffs by protecting by micro-organisms(cid:146) and antioxidants as (cid:145)substances which prolong the shelf-life of foodstuffs by protecting them against deterioration caused by oxidation, such as fat rancidity and colour changes(cid:146). For this category of additive, Article 2(1) of the Directive provides that only substances listed in Annex III may be used in foodstuffs for the purposes mentioned in Article 1(3). Article 2(4) provides that the additives listed in Annex III may only be used in the foodstuffs referred to in that Annex and under the conditions specified therein. Annex III, Part B specifies, in the form of a table, the conditions of use for sulphur dioxide (E 220) and sulphites (6): sodium sulphite (E 221), sodium hydrogen sulphite (E 222), sodium metabisulphite (E 223), potassium metabisulphite (E 224), calcium sulphite (E 226), calcium hydrogen sulphite and potassium hydrogen sulphite (E 228) (7): (E 227), (3) Sundhedsministeriets bekendtgłrelse nr. 1055 af 18 December 1995 om tils(cid:230)tningsstoffrer til j. nr. 95-3400-24. Levnedsmiddelstyrelsen, j. nr. 100-0066. Lovtidende A h(cid:230)fte 198 udgivet den 30 December 1995 s. 5571. GBEK. levnedsmidler. Sundhedsmin. , (4) Fortegnelse over levnedsmidler-Positivlisten (Levnedsmiddelstyrelsen Sundhedsministeriet). Publikation nr. 231, December 1995. tils(cid:230)tningsstoffer til (5) Lovtidende A 1996 h(cid:230)fte 145 udgivet den 23 September 1996 s. 5089. GBEK. (6) The term (cid:145)sulphite agents(cid:146) comprises both sulphur dioxide and sulphites. In the present Decision, the term (cid:145)sulphites(cid:146) will be used to describe (cid:145)sulphite agents(cid:146). (7) These extracts from the Directive are reproduced for information purposes. They do not create any right or obligation other than those deriving from the text of the Directive as published in its entirety in the Official Journal of the European Communities. Only the latter text is authentic. Foodstuff Maximum level in relation to the quantity available (mg/kg or mg/l, as appropriate) expressed as SO2 Burger meat with a minimum vegetable and/or cereal content of 4 % Breakfast sausages Longaniza fresca and butifarra fresca Dried salted fish of the Gadidae species Crustaceans and cephalopods: (cid:151) fresh, frozen and deep-frozen Crustaceans, penaeidae solencerides, Aristeidae family: (cid:151) up to 80 units (cid:151) between 80 and 120 units (cid:151) over 120 units (cid:151) cooked Dry biscuits Starches (excluding starches for weaning foods, follow-on formulae and infant formulae) Sago Pearl barley Dehydrated granulated potatoes Cereal- and potato-based snacks Peeled potatoes Processed potatoes (including frozen and deep-frozen potatoes) Potato dough White vegetables, dried White vegetables, processed (including frozen and deep-frozen white vegetables) Dried ginger Dried tomatoes 450 450 450 200 150 200 300 50 50 50 30 30 400 50 50 100 100 400 50 150 200 22. 12. 1999 EN Official Journal of the European Communities L 329/3 Foodstuff Maximum level in relation to the quantity available (mg/kg or mg/l, as appropriate) expressed as SO2 Foodstuff Maximum level in relation to the quantity available (mg/kg or mg/l, as appropriate) expressed as SO2 Horseradish pulp Onion, garlic and shallot pulp Vegetables and fruits in vinegar, oil or brine (except olives and golden peppers in brine) Golden peppers in brine Processed mushrooms (including frozen mushrooms) Dried mushrooms Dried fruits (cid:151) apricots, peaches, grapes, plums and figs (cid:151) bananas (cid:151) apples and pears (cid:151) other (including nuts in shell) Dried coconut Candied, crystallised or Glico fruit, vegetables, angelica and citrus peel Jam, jelly and marmalade as defined in Directive 79/693/EEC (except extra jam and extra jelly) and other similar fruit spreads including low-calorie products Jams, jellies and marmalades made with sulphated fruit Fruit-based pie fillings Citrus-juice based seasonings Concentrated grape juice for home wine-making Mostarda di frutta Jellying fruit extract, liquid pectin for sale to the final consumer Bottled whiteheart cherries, rehydrated dried fruit and lychees 800 300 100 500 50 100 2 000 1 000 600 500 50 100 50 100 100 200 2 000 100 800 100 Bottled, sliced lemon 250 Sugars as defined in directive 73/437/EEC, except glucose syrup, whether or not dehydrated Glucose syrup, whether or not dehydrated Treacle and molasses Other sugars Toppings (syrups for pancakes, flavoured syrups for milkshakes and ice cream; similar products) Orange, grapefruit, apple and pineapple juice for bulk dispensing in catering establishments Lime and lemon juice Concentrates based on fruit juice and containing not less than 2,5 % barley (barley water) Other concentrates based on fruit juice or comminuted fruit; capilØ groselha 15 20 70 40 40 50 350 350 250 Non-alcoholic flavoured drinks containing fruit juice 20 (carry-over from concen- trates only) Non-alcoholic flavoured drinks containing at least 235 g/l glucose syrup Grape juice, unfermented, for sacramental use Glucose-syrup-based confectionery Beer, including low-alcohol and alcohol-free beer Beer, with a second fermentation in the cask 50 70 50 (carry-over from the glucose syrup only) 20 50 L 329/4 EN Official Journal of the European Communities 22. 12. 1999 Foodstuff Wine Maximum level in relation to the quantity available (mg/kg or mg/l, as appropriate) expressed as SO2 In accordance with Council Regulations (EEC) No 822/87, (EEC) No 4252/88, (EEC) No 2332/92 and (EEC) No 1873/84 and their implement- ing Regulations. Alcohol-free wine Made wine Cider, perry, fruit wine, sparkling fruit wine (including alcohol-free products) Mead Fermentation vinegar Mustard, excluding Dijon mustard Dijon mustard Gelatin Vegetable- and cereal-protein-based meat, fish and crustacean analogues 200 260 200 200 170 250 500 50 200 (5) The Danish Order of 23 September 1996 introduces an Annex, Annex No 9, into the Order of 18 December 1995, specifying in the form of a table the conditions of use of sulphites other than those covered by Community Regulations on wine (8): Foodstuff Garlic pulp Horseradish pulp Apricots Maximum quantity added (mg/kg or mg/l, as appropriate) expressed as SO2 300 600 1 000 (8) These extracts from the Danish legislation are reproduced for information purposes. They do not create any right or obligation other than those deriving from legal texts that have been adopted in law and published in the official Danish publications. Only the latter texts are authentic. Foodstuff Maximum quan- tity added (mg/kg or mg/l, as appropriate) expressed as SO2 Granulated potatoes Jams, jellies, marmalades and chestnut puree (covered by Directive 79/693/EEC) Other jams Glucose-syrup-based confectionery Dry biscuits Deep-water fresh lobster Frozen crustaceans Cooked crustaceans Sugar products (covered by Directive 73/437/EEC) Glucose syrup Vinegar with an acid content of 8 % Lime juice Lemon juice Flavoured drinks based on concentrated fruit juice Beer Cider and perry Fruit wine 100 50 50 50 150 30 30 30 15 20 100 100 300 20 20 50 300 4. Nitrites and nitrates (6) Article 1(3) of Directive 95/2/EC on food additives other than colours and sweeteners provides a definition of preservatives and antioxidants (9). For this category of additives, Article 2(1) provides that only substances listed in Annex III may be used in foodstuffs for the purposes (9) See recital 4 of this Decision. 22. 12. 1999 EN Official Journal of the European Communities L 329/5 Potassium nitrite (E 249) and sodium nitrite (E 250) Foodstuff Quantity added (mg/kg) mentioned in Article 1(3). Article 2(4) provides that the additives listed in Annex III may only be used in the foodstuffs referred to in that Annex and under the conditions specified therein. Annex III, Part C specifies, in the form of a table, the conditions of use for potassium nitrite (E 249), sodium nitrite (E 250), sodium nitrate (E 251) and potassium nitrate (E 252) (10): Potassium nitrite (E 249) and sodium nitrite (E 250) Foodstuff Indicative ingoing amount (mg/kg) Residual amount (mg/kg) Non-heat-treated, cured, dried meat products 150 50 Other cured meat products and canned meat products 150 100 Foie gras, foie gras entier, blocs de foie gras Cured bacon 175 Non-heat-treated meat-based products derived from whole pieces of meat, including slices of products Bacon of the Wiltshire type and related cuts, including saltcured ham Heat-treated meat-based products derived from whole pieces of meat, including slices of products Rullepłlse (rolled meat sausage) Entirely preserved or semi-preserved heat-treated meat-based products derived from whole pieces of meat, including slices of products Bacon and related cuts of the Wiltshire type, including saltcured ham Sodium nitrate (E 251) and potassium nitrate (E 252) Non-heat-treated meat-based products derived from minced meat Foodstuff Indicative ingoing amount (mg/kg) Residual amount (mg/kg) Cured meat products 300 250 Canned meat products Hard, semi-hard and semi-soft cheese Dairy-based cheese analogue Pickled herring and sprats 50 200 Fermented Danish salami Entirely preserved or semi-preserved non-heat-treated meat-based products derived from minced meat Heat-treated meat-based products derived from minced meat Meatballs or liver patØ Entirely preserved or semi-preserved heat-treated meat-based products derived from minced meat 60 150 60 100 150 150 60 100 150 60 150 150 (7) The conditions of use for nitrates and nitrites in foodstuffs other feature in the than meat products positive list (11), to which the Order of 18 December 1995 refers in its paragraph 11. The Commission has they examined these provisions and has decided that comply with the corresponding provisions of Directive 95/2/EC. The Danish Order of 23 September 1996 introduces an Annex 8 into the Order of 18 December 1995, specifying, in the form of a table, the conditions of use of nitrites and nitrates in meat products (12): (10) See footnote 7 of this Decision. (11) See footnote 4 of this Decision. (12) See footnote 8 of this Decision. Sodium nitrate (E 251) and potassium nitrate (E 252) Foodstuff Quantity added (mg/kg) Bacon of the Wiltshire type and related cuts, including saltcured ham Bacon of the Wiltshire type and related cuts, including saltcured ham 300 300 L 329/6 EN Official Journal of the European Communities 22. 12. 1999 THE PROCEDURE soon as notification. they had received the complete, official (8) When the Council adopted Directive 95/2/EC on 15 December 1994 as an A item, the Danish delegation (cid:145)The asked to make a voting declaration, as follows: Danish delegation votes against the the adoption of European Parliament and Council Directive on food additives other than colours and sweeteners. With regard to the use of nitrites/nitrates, sulphites and sodium aluminium phosphates, the Directive does not respond satisfactorily to health requirements, to which the Danish importance in provisions delegation ascribes a crucial regulating food additives. [(cid:133)] In addition, the Danish Government remains firmly convinced that the Scientific Committee for Food ought, in accordance with the declarations put forward by the Commission, to deliver an opinion on nitrites/nitrates and sulphites as soon as possible. The Government will welcome the conclusions of to the Scientific Committee and reserves the right maintain national provisions needed to safeguard human life and health in accordance with Article 100a(4) of the Treaty(cid:146). Directive 95/2/EC was signed by the Presidents of the European Parliament and of the Council on 20 February 1995. The Directive provides that Member States are required to bring into force national measures implementing the Directive by 25 September 1996. a to letter Union concerning intends (9) The Permanent Representation of Denmark to the European the addressed Secretariat-General of the Commission on 15 July 1996. By means of this letter, the Danish authorities forwarded to the Commission a copy of their national measures to implement Directive 95/2/EC (13). The Danish authorities pointed out, however, that (cid:145)Denmark has not transposed the provisions in Directive 95/2/EC concerning nitrates and nitrites in meat products and concerning sulphites (see comparative table). Reference should be made to the voting declaration made by Denmark when the Directive was adopted. Pursuant to former Article 100a(4) of the these Treaty, the Danish to apply its national measures, Government which are justified by the major needs referred to in Article 36. Please enclosed scientific report(cid:146) (14). Given the incomplete character of the file at this stage, the Commission departments did not consider this letter was a formal notification within the that meaning of Article 100a(4). In parallel with this communication, correspondence was exchanged between the competent Danish Minister and the competent Member of the European Commission. The Minister confirmed the Danish position as expressed in the voting declaration. The Commission Member took note of Denmark’s intention to ask for a derogation from the Directive under Article 100a(4), the Commission departments would examine this request as substances, to the adding refer that contacts, the Order which was the subject of (10) The Commission departments were made aware of Order No 834 of 23 September 1996 through a complaint introduced in November 1996. In a letter requesting information addressed to the Danish authorities on 20 January 1997 to follow up this complaint, Commission officials considered that the intention expressed by the Danish authorities in July 1996 to derogate from Directive 95/2/EC had been followed by the later the adoption of complaint. Following informal the Danish authorities provided a detailed reply on 20 May 1997 to the Commission letter asking for more information. An examination of all the various items of correspondence led Commission officials to regard the letter dated 15 July 1996 from the Danish authorities, when read together with their detailed letter of 20 May 1997, as being equivalent to notifying their legislation on nitrites, nitrates and sulphites, pursuant to Article 100a(4) of the the same time, other complaints were EC Treaty. At reaching the Commission denouncing obstacles to the marketing in Denmark of foodstuffs containing sulphites and meat products containing nitrites and/or nitrates. Further informal talks were held between Commission officials and the Danish authorities in order to discuss the scientific and technical aspects of this dossier. These contacts did not make it possible to reach a common position. The only agreement the Danish authorities would forward further information to the Commission to bolster the justifications needed to support their request for a derogation. This additional information was addressed to the Commission on 14 July 1998. reached was that (11) The notification file, comprising the memorandum attached to the letter of 15 July 1996 and the additional information last forwarded by the Danish authorities, was then forwarded to the other Member States for their from opinions. The Commission received opinions Germany, France, the Netherlands, Portugal, Finland, Sweden and the United Kingdom. (cid:151) Germany points out that the conditions of use of sulphites, nitrites and nitrates in foodstuffs were determined taking account of the evaluations of the it would be SCF. Germany nevertheless feels that useful the documentation forwarded by the Danish authorities, examine invite SCF the to to (13) See recital 3 of this Decision. (14) (cid:145)Memorandum(cid:146) on the evaluation of safety and of other aspects of using nitrates and sulphites in (cid:145)foodstuffs(cid:146), hereinafter referred to as (cid:145)the memorandum(cid:146) (cid:151) France thinks the Danish that, on some points, legislation appears discriminatory. France recognises that it would be useful to re-examine at Community level the conditions of use of sulphites, nitrites and 22. 12. 1999 EN Official Journal of the European Communities L 329/7 nitrates, and believes that it would be preferable to await the results of studies on the consumption of food additives carried out by the Member States before undertaking this re-examination, LEGAL ASSESSMENT 1. Applicable rules support (cid:151) The Netherlands does not the Danish derogation request, since it thinks that the Danish authorities their are particularly justified on restrictive measures the Danish account of population, eating habits of demonstrated have that not the (cid:151) Portugal recalls that the reasons invoked by the Danish authorities in their request for a derogation had already been put forward during the discussions preceding the adoption of Directive 95/2/EC, but had not Portugal recommends waiting for the results of the studies on the consumption of food additives to see whether the conditions of use of additives as provided for in the Directive should be changed, the Council. accepted been by (cid:151) Finland understands the concern of the Danish authorities to see the conditions of use of nitrites, nitrates and sulphites in foodstuffs tightened up. Finland points out that Directive 95/2/EC ought to be reviewed on these points, depending on the assessments of the levels of consumption of additives in the Member States, which should be available at the end of 1999, (cid:151) Sweden believes that it has no reason to oppose the Danish rules, considering that it will be necessary to the additives in review the conditions of use of question in the Community, and stating that the application of the Danish rules does not appear to hamper trade, (cid:151) The United Kingdom affirms the Danish authorities have not supplied proof that the risk is greater for Danish consumers than for those in the other Member States. that (13) The Treaty of Amsterdam does not contain any specific transitional provisions concerning the rules applicable to notifications made before the date of entry into force of this Treaty, such as the Danish notification which is the specific this Decision. subject of In the absence of former extending provisions the provisions of Article 100a(4) of the EC Treaty are considered abrogated from the day of the entry into force of the new provisions (1 May 1999). application, their submitted under the notification which it the new provisions of the form of (14) The Commission has informed the Kingdom of Denmark that the provisions of the former Article 100a(4) of the EC Treaty has been regarded as maintained within the framework a of comparison of the provisions of Article 100a(4) of the EC Treaty and the new provisions of Article 95(4) and (6) of the said Treaty, reveals that these are identical. These new provisions of the Treaty, which have replaced the old provisions of Article 100a(4) since 1 May 1999, thus constitute the law which is applicable when examining this notification. comparable, where not this Treaty. Indeed, 2. Consideration of admissibility (15) The notification presented by the Danish authorities seeks to obtain authorisation to maintain certain national provisions which are incompatible with Directive 95/2/EC, which constitutes a harmonisation measure adopted on the basis of the former Article 100a (which has since become Article 95) of the EC Treaty. Indeed, although the letters dated 15 July 1996 and 20 May 1997 from the Danish authorities to national provisions which postdate the adoption of Directive 95/2/EC, it is necessary to note, as indicated in recital 3, substantially reproduce that national rules which existed before its adoption. It must therefore be considered that, in the case in point, the condition provided for in Article 95(4) of the Treaty has been fulfilled, according to which rules notified under this provision are those which a Member State wishes to (cid:145)maintain(cid:146) following the adoption of a harmonisation measure. the national provisions refer (16) substantially of Amsterdam amended (12) On 1 May 1999, the Treaty of Amsterdam amending the Treaty on European Union, the Treaties establishing the European Communities and certain related acts, signed at Amsterdam on 2 October 1997, entered into force. The Treaty the provisions of Article 100a of the Treaty establishing the European Community, replacing paragraphs 3, 4 and 5 of this Article by eight new paragraphs, numbered from 3 to 10. The Article amended in this way became, due to the new numbering of the Articles, Article 95 of the Treaty establishing the European Community. By letter dated 29 July 1999, the Commission informed the Danish authorities that their notification on the use of sulphites, nitrites and nitrates in foodstuffs had been taken into account within the framework of the new provisions of the Treaty. the Secretariat-General of its authorities the Danish the Commission was informed by the In addition, intention to maintain Kingdom of Denmark of national measures which were incompatible with Directive 95/2/EC before the date on which this Directive was to be implemented. Indeed, with their letter of 15 July 1996, the Commission of their intention to maintain their national provisions derogating from Directive 95/2/EC. This initial supplemented by later communications which letter, a clarified its description of the derogating national provisions. In the case in point, therefore, the Commission was aware of the Danish derogation measures as from July 1996, which is before the time limit for the implementation of measures to transpose the Directive. exact meaning, did indeed include informed L 329/8 EN Official Journal of the European Communities 22. 12. 1999 (17) In the light of the above considerations, the Commission believes that the notification made by the Kingdom of Denmark is admissible under Article 95(4) of the EC Treaty. 3. Assessment of the merits (18) (19) therefore verify whether In accordance with the key provisions of Article 95(4) of the EC Treaty, the Commission must ascertain that the national provisions notified are justified by the major needs referred to in Article 30 of the EC Treaty (formerly Article 36 of the Treaty) or which concern the protection of the environment or the working environment. In their letter of notification, the Danish authorities invoke the objective of safeguarding public health. The Commission are must necessary and proportionate to the objective pursued. When the Commission has concluded that the national notified provisions are justified, then verify, pursuant to Article 95(6) EC, whether these measures constitute or not a means of arbitrary discrimination or a disguised restriction on trade between Member States and whether or not they constitute an obstacle to the functioning of the internal market. In addition, it should be pointed out that, from now on, Article 95(4) of the Treaty expressly compels Member States to prove that these conditions are fulfilled in order for a derogation to be authorised. these measures it must (a) Justification with regard to the major need to protect public health (i) Sulphites on Directive framework to justify their In their memorandum, the Danish authorities base their 89/107/EEC argument concerning additives for a derogation. Annex II of this Directive sets out general criteria for food additives. The Danish authorities criticise the Community legislators for not having followed these criteria to establish the conditions of use of sulphites in foodstuffs when Directive 95/2/EC was adopted. the use of request (20) However, the elements put forward by the Danish authorities with regard to two of the criteria defining the conditions of use of additives, namely technological need and the risk of misleading consumers, have nothing to do with the objective of public health protection as mentioned in Article 30 of the EC Treaty, neither do they refer to the other objectives listed in Article 95(4) of this Treaty. These elements are not in any case pertinent, therefore, if they are compared with the limited cases for justification that have been listed in the abovementioned Article 95(4), and the Commission believes, moreover, that the arguments put forward are not founded. (21) As far as the technological need is concerned, the Danish authorities insist on the need for a strict framework for the conditions of use of sulphites in foodstuffs and stress the fact that, since the introduction in 1988 in Denmark of a restrictive legislation regarding the use of these additives, several of the foodstuffs mentioned in Directive 95/2/EC have been marketed in Denmark without the addition of sulphites and with no problem for food safety. The Danish authorities quote the example of peeled potatoes, mustard, dried fruits and canned fruits and vegetables. The Commission affirms that Community legislation took proper account of the need for a strict framework for the conditions of use of sulphites in foodstuffs. are authorised as preservatives and/or antioxidants (15) by Directive 95/2/EC, and that these additives thus perform a a technological need which cannot be satisfied by other economically and technologically usable methods. The this argument Commission believes, moreover, cannot be invoked for the purposes of public health protection, since it is up to the Danish authorities to establish that the presence of sulphites constitutes a risk to public health. specifies, however, technological correspond sulphites function that that and to It be are regarded (22) Turning to the risk of misleading consumers, the Danish authorities question once again the justification for using sulphites established by Directive 95/2/EC, believing that these additives have a bleaching effect on fruit and vegetables, which could possibly as that misleading consumers. The Commission recalls sulphites authorised by Directive 95/2/EC as preservatives and/or antioxidants, but not as bleaching agents. The function of antioxidants to (cid:145)protect [foodstuffs] against deterioration caused by oxidation, changes(cid:146) (16). The Commission such as believes that a function of lead a this kind cannot consumer to be misled as to the nature of the product, given that the product labelling mentions the presence of the additive in question. What is more, this argument could not constitute a justification with regard to the objective of public health protection. colour [(cid:133)] is (23) The specific community directives on additives were adopted on the basis of a rigorous safety assessment of all the additives carried out by the SCF so that only those additives whose use in foods was judged risk-free would feature in the specific directives and could hence be used in the Community. Annex II to Directive 89/107/EEC provides that (cid:145)to assess the possible harmful effects of a food additive or derivatives thereof, it must be subjected to appropriate toxicological testing and evaluation. The evaluation should also take into account, for example, any cumulative, synergistic or potentiating effect of its use and the phenomenon of human intolerance to substances foreign to the body(cid:146). On several occasions the SCF has been called on to carry out a toxicological the last being in an opinion evaluation of sulphites, (15) See the definitions of preservatives and antioxidants in recital 4. (16) Article 1(3)(b) of Directive 95/2/EC. 22. 12. 1999 EN Official Journal of the European Communities L 329/9 delivered on 25 February 1994 (17). The Danish authorities are using this opinion as a basis for their argument exceeding the acceptable daily intake (ADI) and the risks of allergies connected with the consumption of sulphites. to condemn the risks of (24) The evaluation of the safety of an additive may highlight the need to establish an ADI to safeguard public health. This ADI represents the quantity which can be safely ingested on average every day throughout a lifetime. The ADI, which comprises a habitual safety factor of 100, which may be as high as 500, is expressed in milligrams per kilogram of body weight (mg/kg bw). The approval of any food additive and the determination of its conditions of use must therefore take into account the technological need for this additive (the quantity needed to reach the desired effect) while simultaneously taking account of the probable daily intake of the additive in all food products, in order to check that the authorised use does not that has been established for the additive in question being exceeded. risk leading to the ADI (25) In its opinion of 25 February 1994, the SCF established an ADI of 0,7 mg/kg bw per day for sulphites (18), corresponding to 49 mg/day for an adult (0,7 mg/kg (cid:215) 70 kg) and 21 mg/day for a child (0,7 mg/kg (cid:215) 30 kg). This value is based on a quantity which has no effect on the gastrointestinal system. The conditions of use of sulphites defined in Directive 95/2/EC may, according to the Danish authorities, lead to the ADI being exceeded. The Danish authorities quote the example of wine, in which sulphites are authorised up to 160 mg/l (19). The consumption of two glasses of wine represents an intake of 40 mg of sulphites (25 cl (cid:215) 160 mg/l) which is not far from the daily admissible intake for an adult. The Danish authorities believe that any additional authorisation of sulphite use will lead to the ADI being exceeded or will increase the risk of its being exceeded. (26) The Danish authorities are not however seeking to tighten up the conditions of the use of sulphites in wine, but their conditions of use in other foodstuffs, such as those defined in Directive 95/2/EC. To tighten up the conditions of use of sulphites, the Danish authorities have reduced the number of foodstuffs in which sulphites (17) Reports of the SCF, 35th series. (18) In its previous opinion on sulphites delivered in 1981, the SCF considered that it was not necessary to set an ADI. (19) Directive 95/2/EC in fact refers back to Council Regulation (EEC) No 822/87 of 16 March 1987 on the common organisation of the market in wine (OJ L 84, 27. 3. 1987, p. 1), last modified by Council Regulation (EC) No 1627/98 of 20 July 1998 (OJ L 210, 28. 7. 1998, p. 8). In its Article 65, this Regulation provides that the total sulphur dioxide content of still wines (cid:145)may not exceed [(cid:133)] 160 mg/litre for red wine, 210 mg/litre for white and rosØ wine(cid:146). may be used. Thus, the Danish Order of 23 September 1996 retains only 16 categories of foodstuffs in which sulphites may be used out of the 61 categories which are included in Directive 95/2/EC. having in mustard, without in the eating habits of (27) The Commission notes that the Danish authorities have not justified the choice which they have made. This choice may appear arbitrary to the extent that the Danish authorities have not indicated how technological need has been demonstrated in some cases and not in others. For example, the Danish authorities prohibit the use of provided sulphites information on the levels of consumption of mustard in Denmark, which would show the importance of this foodstuff the population and hence the need to outlaw the use of sulphites in this product in order to reduce the sulphite intake in the diet as a whole. To tighten up the conditions of use of sulphites in some foodstuffs the Danish authorities have lowered the levels of use of sulphites (20). The Danish Order of 23 September 1996 determines the added quantity, which is the opposite of Directive 95/2/EC, which determines the maximum quantity available in the finished product (21). For example, the use of sulphites in dehydrated potato granules is authorised up to a level of 100 mg/kg in Denmark, while Directive 95/2/EC authorises a total available quantity of 400 mg/kg of sulphites. The Danish authorities have not justified this measure and, more specifically, have not taken account of the fact that the use of sulphites is authorised by foodstuffs, Directive 95/2/EC in a certain number of including dehydrated potato granules, which can only be consumed after cooking or reconstitution. It is precisely these treatments which reduce substantially the sulphite content in foodstuffs when they are consumed. The Commission is therefore inclined to question the choice made by the Danish authorities of the foodstuffs in which sulphites may be used. (28) The Commission points out that the Community provisions on sulphites are still likely to be the subject of a review. The safeguard clause provided for in Article 4 of Directive 89/107/EEC may lead to the changing of the positive list. Article 7 of Directive 95/2/EC, which imposes on the Member States and on the Commission the tasks of monitoring additive consumption trends, should permit a re-examination of the conditions of use of the additives provided for in the Directive and lead to its adaptation. (20) It is not feasible to lower generally the levels of use of sulphites in foodstuffs. The levels of use which feature in the Directive were calculated to produce intrinsic technological function of these additives; below such levels, the desired effects are not produced. effects which are the the (21) See the first footnote of Annex III, Part B, to Directive 95/2/EC. For dry biscuits, for instance, the quantity allowed in the Danish Order is as a result higher than that which features in Directive 95/2/EC. Nevertheless, the Danish authorities do not specify that the maximum level in the finished product is not higher than that set by the Community text. L 329/10 EN Official Journal of the European Communities 22. 12. 1999 (29) Apart from the question of exceeding the ADI, the Danish authorities stressed the risk of allergic reactions caused by sulphites which may occur in certain predisposed individuals at low levels of exposure. The Danish authorities refer here directly to the opinion of the SCF of 25 February 1994 to insist on the need to limit the use of sulphites to as small a number of products as possible and to provide information for consumers on the presence of sulphites in foodstuffs. (30) The Commission acknowledges that allergic to the risks of sulphites, food allergies in so far as it like a certain number of other additives, may provoke allergic reactions in certain individuals and points out that these risks of allergies have been taken into account in the Community legislation. The Commission believes that the Community legislation provides an appropriate response to the problem of in general. The Community legislator admits that it is perfectly legitimate is possible, subjecting such to avoid, reactions. The individuals Community legislator did not nevertheless deem it necessary to outlaw generally the use of these allergenic such a sulphites ingredients, among which additives feature. The solution opted for at Community level is individuals who suffer based on informing consumers: from an allergy attributable to certain ingredients should have the possibility of choosing to consume foodstuffs which do not contain these ingredients. Council Directive 79/112/EEC of 18 December 1978 on the labelling of foodstuffs (22) offers them this possibility since it provides for the compulsory listing of ingredients on the labelling to Article 6 of of Directive 79/112/EEC, a technological function must of necessity be mentioned on the labelling. Thus sulphites appear in the list of ingredients. The Commission believes, that existing Community legislation gives consumers or, when such consumers are children, gives their parents or members of their entourage, such as officials in schools, a guarantee of sufficiently clear and detailed information as regards the presence of sulphites in foodstuffs. In particular, pursuant all additives which serve foodstuffs. therefore, (32) (31) The Commission acknowledges that the labelling does not always indicate the presence of sulphites in certain circumstances. This is the case of sulphites which, having remain been used in the preparation of present that stage serving any technological function (23). This is also the case of sulphites which are present in a large number of in the finished product without at foodstuffs, such as foodstuffs without having been voluntarily added (24). These two examples correspond to very low levels of sulphites which may nevertheless cause allergies in some individuals. The Commission notes that the regulation applicable in Denmark does not solve this problem of a lack of labelling of sulphites with such low content levels. Work is in progress at community level to make it systematically compulsory to label allergenic ingredients such as the sulphites quoted in the examples above. Information for consumers on the presence of sulphites could also be incomplete as regards foodstuffs offered for sale which have not been prepackaged. The Commission would point out that Article 12 of Directive 79/112/EEC to decide on the manner of allows Member States labelling such foodstuffs, the obligation of affixing descriptions to accompany products sold loose (without prepackaging) and containing certain particulars regarding these products. to inform all consumers fully about the content of some foodstuffs, Member States may thus oblige restaurant owners to record on the menu the list of ingredients of the dishes that they offer. The Danish authorities also evoke the case of alcoholic beverages, in whose labelling the list of ingredients does not necessarily appear. The Commission would stress that, pursuant to Article 6(3) of Directive 79/112/EEC, for a European Parliament and Council Directive amending Directive 79/112/EEC, aimed at making the labelling of ingredients in alcoholic drinks (25) compulsory. This proposal for a formulated by the Directive follows other proposals Commission in the past but which led to no tangible result. That is why the Commission did not propose the adoption by some Member States of national legislations making the indication of ingredients compulsory in the labelling of certain alcoholic beverages. it presented a proposal In order specifically, of In the light of the information supplied by Denmark, the Commission also examined whether sulphites constituted a particular health problem for the Danish population as compared with the populations of the other Member States. In their memorandum, the Danish authorities did not refer to any epidemiological study, did not offer any data on the prevalence of food allergies nor of allergies to additives nor, more to sulphites which would have made it possible to make comparisons with the averages for the European or world population with a view to establishing whether the Danish population is in a specific situation with regard to the prevalence of allergies to sulphites. The Commission has no knowledge of any such studies concerning Denmark or any other Member State or any third country. The Commission also tried to analyse the situation in greater detail by referring to a report issued by the SCF on 22 September 1995 concerning adverse of reactions ingredients foodstuffs allergies and the to (22) OJ L 33, 8. 2. 1979, p. 1. Directive as last amended by Directive 97/4/EC of 27 January 1997 (OJ L 43, 14. 2. 1997, p. 2). (23) Article 6(4)(c)(ii) of Directive 79/112/EEC. Apart from the foodstuffs to which the provisions of Directive 95/2/EC are applicable with respect to sulphites, sulphites may legally be transferred to a certain number of other foodstuffs in accordance with Article 3(1) of this Directive through the application of the carryover principle. (24) The second footnote of Annex III, Part B to Directive 95/2/EC specifies for this reason that sulphites whose content does not exceed 10 mg/kg are not considered to be present in the finished product. (25) Proposal for a Directive published in OJ C 106, 4. 4. 1997, p. 5. 22. 12. 1999 EN Official Journal of the European Communities L 329/11 present allergens In this report, regions where foodstuffs (26). the SCF indicates that, according to the available studies carried out throughout the world, (cid:145)the prevalence of food allergy is clearly less than 1 % in the adult population and may be slightly higher in the case of children(cid:146). The SCF mentions several studies which reveal that this prevalence when related more specifically to food additives is less than 0,1 % for the population. But it mentions a further crucial element in its report, namely that genetic and environmental factors as well as eating habits may increase the prevalence of food allergies. The SCF quotes the example of the are It also quotes the case of regions where environment. allergens are widely consumed. Consequently, the SCF concludes that (cid:145)the prevalence of food allergy depends greatly on the geographical region(cid:146). The Commission therefore felt bound to check whether the Danish authorities had actually supplied proof of the existence and importance of such factors, linked to genetics, the environment or eating habits. The Commission has not detected anything in the memorandum which throws the existence of any of these factors into relief. Consequently, the information available to the Commission has not made it possible to conclude that the Danish population is in a specific situation compared with the populations of immediate neighbours, as regards this question of allergies related to sulphites. other Member notably States, its in (33) What is more, the Commission finds that the Danish measures as notified are inconsistent with the declared objective of protecting public health. the restrictive measures refer only to sulphites. Sulphites, however, are not the only additives which present allergy risks. We may also quote the example, based on the already quoted report by the SCF of 22 September 1995, of benzoates and certain colourings such as azo dyes. The Commission observes that these various sources of allergies have not been subject to the same sort of restrictions as those applicable to sulphites in Denmark. Indeed, (34) the Commission is led to In the light of these facts, conclude that though based on public health considerations, are still not justified by the need to protect public health. the Danish measures, (ii) Nitrites and nitrates (35) The Danish authorities want to maintain their restrictive provisions regarding the use of nitrites and nitrates in meat products. The conditions of use for these additives in cheese and in fish as laid down in Directive 95/2/EC have not been questioned. The Danish Order of 23 September 1996 authorises the use of nitrites in the meat products referred to in Directive 95/2/EC within limits lower, on average, than half those provided for by the Directive, except for bacon of the Wiltshire type and (26) SCF reports, 37th series. rolled meat sausage (rullepłlse), in which levels of nitrites used may be comparable to those provided for by the Directive. The use of nitrates is not authorised by the Order of 23 September 1996 in any of the products referred to in the Directive, except the Wiltshire type, at levels close to those provided for in the Directive. The Danish authorities are keen to apply their restrictive measures since they believe that the use of nitrites and nitrates in meat products in the conditions set out in Directive 95/2/EC is not necessary from the technological viewpoint and that these additives present a danger to health (27). in bacon of that nitrites to inhibit or halt such (36) Nitrites and nitrates are used in meat products as preservatives (28) the growth of Clostridium as undesirable micro-organisms botulinum, the bacterium responsible for botulism, or Staphylococcus aureus. The Danish authorities do not and nitrates perform such a contest technological function, but consider that the levels of use of these additives set out in Directive 95/2/EC exceed what is required to satisfy this technological need. It is all the more important to limit the conditions of use of nitrites and nitrates to what is strictly necessary given that there are particular health risks which are connected with these additives (29). The Danish authorities refer to reports by the Danish National Food Agency showing that restrictive conditions of use of nitrites and nitrates in force in Denmark since the adoption of Directive 95/2/EC have not led to cases of botulism among the population. Experiments carried out in Denmark during the production phase and based, in particular, on the application of the HACCP (30) system regarding hygiene the levels of nitrites and nitrates in meat show that products provided for in the Danish regulation are sufficient from the technological standpoint. (37) The Commission does not share the Danish authorities’ view and considers that the conditions of use of nitrites in meat products defined in Directive and nitrates 95/2/EC correspond to what required from the technological viewpoint in order to achieve the desired effects. The Commission observes that the Danish Order of 23 September 1996 authorises the use of nitrites and nitrates in conditions comparable to those of Directive 95/2/EC in two types of meat product: bacon of the is (27) This would mean that the three cumulative conditions for the authorisation of additives set out in Directive 89/107/EEC would not be fulfilled. the first two of in (28) The technological function of these additives is to extend the shelf life of foodstuffs by protecting them from deterioration due to micro-organisms, of accordance with preservatives given in Article 1(3)(a) of Directive 95/2/EC. The use of nitrites and nitrates also has direct consequences on the determination of the final date for the consumption of a product in that they make it possible to retain the water which the meat product contains naturally in order to preserve its organoleptic qualities, particularly its aromas, colour and texture. definition the (29) These risks are described in recitals 35 et seq. of this Decision. (30) HACCP denotes the (cid:145)Hazard analysis and critical control points(cid:146) system. See Article 3 of Council Directive 93/43/EEC on the hygiene of foodstuffs (OJ L 175, 19. 7. 1993, p. 1). The Directive does not however deal with meat products during the stages preceding their sale to the final consumer. L 329/12 EN Official Journal of the European Communities 22. 12. 1999 explained why Wiltshire type and rolled meat sausage (rullepłlse). The these Danish authorities have not products, which are, moreover, traditional Danish products, require higher levels of nitrites and nitrates than other meat products. The Commission does not see that there are any substantial differences between these categories of products which could justify discriminatory treatment of this kind. cells and tumours substance, there is no threshold below which the can be formation of cancerous excluded. It is therefore vital to reduce the exposure to preformed nitrosamines present in foodstuffs by using appropriate technological methods the minimum needed to obtain the desired preservative effect and to guarantee microbiological safety. to arrive at for such these required additives Clostridium levels of nitrites (38) The Commission confirms that the conditions of use of nitrites and nitrates in meat products do not exceed what to perform their is technological function. Nitrites and nitrates used in meat products tend to inhibit or halt the growth of undesirable micro-organisms botulinum. as Contamination of meat products by this bacterium is likely to occur throughout the food production process, particularly at the carcasse-cutting stage, during the production process, up to and including the consumption stage (31). The and nitrates must therefore be calculated so that these additives fulfil their role as preservatives right up to the last stage of the food production and consumption process. But from the moment they have been incorporated into meat products, the quantities of nitrites and nitrates diminish time and transform considerably over a period of themselves is why Directive 95/2/EC determines both the indicative ingoing amount and the residual amount. The Danish Order of 23 than Directive September 1996 is more 95/2/EC: it determines only the quantities of nitrites and nitrates added and these quantities are generally lower than the indicative ingoing amounts defined in the Directive. The Order does not therefore guarantee that the presence of additives in products at the end of the food production process is sufficient to perform their technological the microbiological safety of products. into nitrosamines. That function, which is to guarantee restrictive that (39) The Danish authorities base their arguments on the opinions of the SCF of 19 October 1990 (32) and 22 September 1995 (33) to denounce the serious health risks connected with nitrites and nitrates. The Danish authorities refer in particular to the latter opinion of the SCF which, having been formulated after the adoption of Directive 95/2/EC, might have contained new elements capable of bringing certain aspects of this Directive into question. In this opinion of 22 September 1995, having recalled that, after their addition to a meat product, into nitrites and these nitrates nitrites lead to the formation of nitrosamines, the SCF specified that (cid:145)there is an obvious correlation between the addition of nitrites for the curing of meat and the formation of volatile nitrosamines(cid:146). Nitrosamines are type of genotoxic, carcinogenic substances. For transform themselves this (31) Infection caused by a consumer when handling the product. (32) Reports of the SCF, 26th series. (33) Reports of the SCF, 38th series. (40) The Danish authorities are of the opinion that legislation does not meet the this health Community protection objective in that it uses an inappropriate methodology. The Danish authorities point out that there is no relation between the quantity of nitrites and nitrates added and the residues which may be detected in the food product ready for consumption, but that there is an (cid:145)obvious correlation(cid:146) between the quantity added and the formation of nitrosamines. According to the Danish authorities, legislation justified by health reasons ought to be based on limiting the quantity added, and not on limiting the residual amount. But Directive 95/2/EC in fact determines the ingoing amounts only indicatively. If there is a need to establish a limit for the residual amount, there is a simultaneous need to establish a limit for the added quantity. The Danish authorities consider that, quite apart the figures for the maximum levels of nitrites and nitrates given in the Directive are too high compared with the minimum needed to obtain the desired preservative effect and to guarantee microbiological safety. The Danish authorities are therefore led to evoke the possibility that the ADI is being exceeded. They do not however give any details, but quote the SCF, which, in its opinion of 22 September 1995, stated that (cid:145)if the levels of nitrite residues were as high as those authorised by Directive 95/2/EC, the ADI could be exceeded(cid:146). from the methodology followed, (41) The Commission notes in the first place that the Danish measures do not appear consistent with the declared objective of health protection in that they do not in any way prevent nitrosamines from forming in products which are widely consumed in Denmark, such as bacon of the Wiltshire type, rolled meat sausage and fermented Danish salami, since the use of nitrites and nitrates is authorised in these products by the Danish Order of 23 September 1996 in conditions which are comparable with those provided for in the Community legislation. by raised fundamental (42) The Commission then examined with particular attention the the Danish questions authorities. In its opinion of 1990, the SCF had already evoked the connection between nitrites and nitrosamines and had recommended reducing the levels of nitrites and nitrates in foodstuffs as much as possible in order to limit exposure by consumers to preformed nitrosamines. The SCF reported a lack of scientific data concerning the regards formation nitrosamines, especially of as 22. 12. 1999 EN Official Journal of the European Communities L 329/13 regard risk management. endogenous nitrosamines, the main source of which is the nitrites naturally present in saliva. Directive 95/2/EC was adopted taking into account all these questions raised by the SCF. In its opinion of 1995, the SCF upheld its opinion of 1990. If the memorandum of the Danish authorities had contained new elements which would help evaluations to progress, the SCF would have been informed at once of the dossier. But the Commission is forced to acknowledge that such is not the case of the information communicated by the Danish authorities. The Commission wishes to insist on the responsibility incumbent on a legislator, whether Community or national, with The to Community legislator did fix the levels of nitrites and nitrates in meat products, precisely in order to achieve the desired technological aim and at the same time to attain the objective of public health protection. Since nitrites and nitrates greatly inhibit the proliferation of they do effectively contribute to Clostridium botulinum, technological need, avoiding cases of botulism. This which the Danish authorities are not questioning for some meat products, such as bacon of the Wiltshire type, is, from the health point of view. The levels of use of these additives have been calculated in order to attain this health objective. It is not however excluded that, in the future, these levels of use could be lowered in Community regulations to take account of possible developments in the HACCP approach with respect to the hygiene of meat products (34). in the Commission’s view, crucial (43) As regards the exceeding of the ADI, the Commission would point out that the SCF has established an ADI of 5 mg/kg bw, expressed as sodium nitrate, for nitrites and an ADI of 0,1 mg/kg bw, expressed as sodium nitrite, for nitrites. The daily admissible intake for an adult is 350 mg (5 mg/kg x 70 kg) in the first case and 7 mg (0,1 mg/kg x 70 kg) in the other. To reach the level of this admissible daily intake, it would be necessary to consume approximately 1 400 g of prepared meat products (350 mg/kg/250 mg/kg) every day in the first in the case and 40 g of bacon (7 mg/kg/175 mg/kg) other. The figures for the nitrates exclude a priori any risk of exceeding the ADI (35). As far as nitrites are concerned, the Danish authorities put forward no data on the levels of consumption of meat products containing nitrites in Denmark. Such data might have justified the restrictive measures and even led to the adaptation of Community legislation on this point. But the Danish authorities have not mentioned any study in their memorandum enabling them to make comparisons with European or world average population, with a view to determining whether the Danish population is in a specific situation with regard to the danger which the use of nitrites and nitrates could represent. In this context the Commission would point the review of Directive 95/2/EC could be out concerning data that the of permit additives trends to the Commission to monitor ought initiated in several ways. The safeguard clause provided for in Article 4 of Directive 89/107/EEC might lead to the amendment of the positive list. Article 7 of Directive 95/2/EC, which makes it compulsory for Member States in the and a consumption reexamination of the conditions of use of the additives provided for in the Directive. Directive 95/2/EC could be reviewed as a result of any new information provided, such as a precise study on the levels of consumption of foodstuffs likely to contain nitrites and nitrates and on the possible need to impose further restrictions on the conditions of use of nitrites in order for consumers not to exceed the ADI. This is not however the case of the information communicated by Denmark to support its request for a derogation. What is more, so far no other Member State has forwarded any such new information to the Commission. (44) The Commission therefore considers that, while the Danish measures are aimed at protecting public health, they are excessive in relation to this aim. (b) Absence of arbitrary discrimination (45) Since the measures in question are not justified by the need to protect public health, the Commission does not have to verify whether this condition is satisfied. (c) Absence of a disguised restriction on trade between Member States (46) Since the measures in question are not justified by the need to protect public health, the Commission does not have to verify whether this condition is satisfied. (d) Absence of an obstacle to the functioning of the internal market (47) Since the measures in question are not justified by the need to protect public health, the Commission does not have to verify whether this condition is satisfied. (34) See note 33 of this Decision. Work is in progress at Community level to examine the possibility of developing the HACCP approach with regard to foodstuffs of animal origin which are not covered by Directive 93/43/EEC. (35) The conditions of use of nitrates were determined taking account of the fact that their use as additives in foodstuffs contributes only a small proportion of the total intake, most of which comes from vegetables and water. CONCLUSION (48) In the light of the above considerations, the Commission concludes that the national provisions notified by the Kingdom of Denmark pursuant to the former Article 100a(4) of the EC Treaty, concerning the conditions of L 329/14 EN Official Journal of the European Communities 22. 12. 1999 use of sulphites, nitrites and nitrates in foodstuffs, though pursuing the objective of protecting public health, which is one of the major needs referred to in Article 30 of the EC Treaty (formerly Article 36 of the Treaty), are not justified since they are not strictly necessary for achieving that objective. The Commission therefore has reason to consider that the national provisions notified cannot be approved, HAS ADOPTED THIS DECISION: Article 1 The Danish national provisions derogating from Directive 95/2/EC notified pursuant to the former Article 100a(4) of the EC Treaty and examined by the Commission pursuant Article 95(4) and (6) are not approved. to Article 2 This Decision is addressed to the Kingdom of Denmark. Done at Brussels, 26 October 1999. For the Commission Erkki LIIKANEN Member of the Commission