Brussels, 1 December 2010
REACH system for safer use of chemicals – frequently asked questions
What is REACH?
REACH, which stands for Registration, Evaluation, Authorisation and Restriction of Chemicals, is a system for ensuring the safe use of chemicals within the EU. The system was set up by EU legislation which came into force on 1 June 2007, creating a single regulatory system for dealing with new and existing chemical substances. REACH seeks to close the knowledge gap that previously existed concerning the risks associated with particular chemicals and to encourage the progressive replacement of dangerous chemicals with safer ones by means of its authorisation system. REACH places greater responsibility on industry to manage the risk of chemicals and provide appropriate safety information to professional users and, as far as the most hazardous substances are concerned, also to consumers.
What are the main benefits of REACH?
The main benefit of REACH is that the hazards and risks of chemicals are more systematically identified, which allows for appropriate risk management measures by industry or, if necessary, further regulatory action by the public authorities.
This will contribute to the prevention of health problems caused by exposure to chemicals, leading to a lower occurrence of diseases and preventable deaths, and, with that, lower costs for the national health systems. The benefits will come gradually as more and more substances are phased into REACH. The anticipated overall benefits to the environment and human health are generally expected to be significant although a quantitative assessment is difficult. The Commission’s Impact Assessment in 2003 developed an illustrative scenario which put the health benefits alone in the order of magnitude of €50 billion over a 30 year period.
The European chemicals industry will benefit from a single EU regulatory system, a decision-making system with clear deadlines, and more consumer confidence in their products. Downstream users of chemicals will get relevant information on the safe use of the chemical substances they use in their production process which will help them to ensure better protection of their workers. The chemicals industry's products will be safer for consumers and the environment and it will be easier to put corporate social responsibility into practice.
What is the purpose of REACH registration?
The aim of REACH registration is to ensure the safe use of chemicals by gathering safety information on the chemical substances available on the EU market in a single and comprehensive database. Enterprises that manufacture or import more than one tonne of a chemical substance per year are required to register the chemical in a central database. This will give industry greater knowledge about the chemicals it uses and whether these are hazardous to human health and the environment. This should ultimately lead to better risk assessment and safer use of chemicals throughout the EU. It will lead to less chemical pollution, greener choices by consumers and industry, and a cleaner environment.
What is the scope of REACH?
REACH covers all chemical substances manufactured in, or imported into the EU in quantities of one tonne or more per year. Registration under REACH is for substances only. However, the provisions of the Regulation apply to the manufacture, placing on the market or use of substances on their own, in preparations or in articles.
What are industry's obligations under REACH?
REACH requires manufacturers and importers of chemical substances to obtain information on the physical and chemical, health and environmental properties of their substances and use this information to determine how these can be used safely. Each manufacturer and importer must submit a registration dossier to the European Chemicals Agency documenting the data and assessments.
All users of dangerous chemicals are obliged to ensure the safe use of those chemicals through risk management measures identified in the registration dossiers and communicated to the users of chemicals through extended Safety Data Sheets. Manufacturers and importers are obliged to register substances they produce or import in quantities over 1 tonne per year. The registration requirement applies to substances on their own, in preparations and in articles under special conditions (intentional release of the substance). Failure to register means that the substance cannot be manufactured, imported or used in the EU.
Downstream users of chemicals – those who use a substance in the course of their industrial or professional activities – must apply the risk management measures for dangerous substances identified by the supplier and communicated via Safety Data Sheets. They have the right to make their use of a substance known to the manufacturer so it can be registered as an identified use and covered in the supplier’s chemical safety assessment. In this case they have to provide sufficient information to enable the supplier to prepare an exposure scenario for the use. Alternatively, for example if they prefer to keep their use confidential for business reasons, they can conduct their own chemical safety assessment and report this use to the chemicals agency.
Who did the 30 November deadline apply to?
The 30 November 2010 deadline applied to EU manufacturers and importers of chemical substances in very large quantities (above 1000 tonnes per year) and the most dangerous ones. Substances that are carcinogenic, mutagenic or toxic for reproduction ("CMR") had to be registered if they are manufactured or imported in a volume of above 1 tonne per year. Substances that are very toxic for the aquatic environment also had to be registered if they are produced or imported in volumes above 100 tonnes per year.
What happens to companies that did not register their substances in time?
Article 5 of the REACH Regulation imposes the principle of "no data no market". Member States are responsible for enforcing this principle, and each Member State has its system in place to check that companies subject to the deadline did register. If a company did not register a substance in time and continues to produce it and put it on the market, it is in breach of the law and can expect to be penalised.
How long will it be until we know how many and which substances have been registered?
The European Chemicals Agency (ECHA) will be busy processing all the registration dossiers in the coming months and must complete this work by the end of February 2011 according to the REACH Regulation. So by then we will know the number of registered substances more precisely – although new substances may still come in and there may also be dossiers that failed the completeness check and which will be registered later.
What kind of information will we learn from this first registration?
We will learn which chemicals that meet the criteria for the first registration deadline are currently on the market, and in what tonnage range. We will also learn what these chemicals are used for, what risks are associated with them and how these risks are managed so they can they be handled safely. All the safety information contained in the registration dossier has to be passed down the supply chain (the downstream users) and the downstream users need to comply with the requirements for safe use within one year after receiving the safety data sheet with the REACH registration number.
This information will be available in a central database hosted by ECHA, which is growing as more registrations come in. REACH registration will lead to a concentration of knowledge that industry as a whole possessed but was divided between different companies all over Europe. Now this information has been brought together in the European Chemicals Agency. This is new and unique in the world.
What happens once companies have successfully registered their substances?
The Agency assigns a registration number after checking that the dossier is complete. This initial check does not include an examination of the quality or the adequacy of the data submitted. REACH stipulates that the quality assessment is carried out independently from the registration process, through a process called Evaluation (the E in REACH).
REACH specifies three independent evaluation processes to meet three distinct objectives:
First, a compliance check is used to check whether the information submitted by registrants is in compliance with the legal requirements.
Second, all testing proposals are examined to avoid unnecessary animal testing. Registrants must seek permission to undertake certain tests by submission of a testing proposal. Testing proposals which include animal tests undergo public consultation.
Third, substance evaluation aims to clarify whether the use of a substance may cause harm to human health or the environment. The substances are selected by the Agency in cooperation with Member States. Substances are evaluated according to priority criteria, considering hazardousness, exposure and volume.
How has industry been affected by the registration process?
Industry has known about registration for many years and large companies started working on their registration dossiers as soon as REACH entered into force or even before. Smaller companies and those who are not part of the chemical sector but use chemicals in the course of their work probably started work on their dossiers at a later stage. REACH has required a lot of work of gathering data. This included setting up or strengthening the use of communication channels between suppliers and customers to find out for example what they are using a certain substance for. But this has also meant exchanging data and testing results in Substance Information Exchange Forums (SIEF) whereby all those who had to register the same substance shared data and shared costs. This process led to new insights into uses of substances and their safety. Registration is a tremendous amount of work but it leads to better safety and improved communication in the supply chain.
What are the next registration deadlines?
31 May 2013: registration deadline for substances manufactured or imported in quantities of 100 tonnes and more.
31 May 2018: registration deadline for substances manufactured or imported in quantities of 1 tonne and more.
Registration prior to the deadline is of course possible. All new substances need to be registered before they are placed on the market.
What is the REACH authorisation process and how will it work in practice?
Authorisation means that the substance may no longer be used or placed on the market unless a company has obtained an authorisation to do so. Substances that are subject to authorisation will be listed in REACH Annex XIV.
The authorisation system is intended to ensure that the risks from such substances are properly controlled and that these substances will be progressively replaced by suitable alternative substances or technologies where these are economically and technically viable.
In particular, there may be applications where exposure to human beings or the environment is very limited and where risks can be adequately controlled. In other cases, the use of such substances can create substantial socio-economic benefits that outweigh the risks associated with the use (e.g. ensuring safety of equipment) and there is no suitable alternative. In these cases, an authorisation will be granted.
For certain substances that are carcinogenic, mutagenic or toxic to the reproductive system (so-called "CMR" substances), an authorisation will be granted if the applicant can show that risks from the use in question can be adequately controlled. This means that scientists can agree on a "safe threshold" below which a substance does not create negative effects to the human body or the environment. For other CMR substances and substances with persistent, bio-accumulative or toxic properties (PBT, vPvB substances), where adequate control is not possible, an authorisation will only be granted if no safer alternative exists and if the socio-economic benefits of the use of the substance outweigh the risks.
What is the Candidate List and how many substances are on it?
The Candidate List is a step in the REACH authorisation process. It is a list of substances of very high concern that have been nominated by the European Commission or by the Member States and decided upon by ECHA after public consultation. These substances may be subject to authorisation later. Currently there are 38 substances on the list. By the end of 2012, there should be 135.
The Candidate List can constitute a reference list for consumers and retailers. When asked by a consumer whether a certain product contains a substance listed on the Candidate List, the retailer has a legal obligation under REACH to reply.
What are the most dangerous substances?
Substances of very high concern are:
carcinogens (category 1a and 1b)
mutagens (category 1a and 1b)
substances which are toxic to reproduction (category 1a and 1b)
persistent, bio-accumulative and toxic substances (PBTs),
very persistent and very bio-accumulative substances (vPvBs)
substances identified from scientific evidence as causing equivalent concern to those mentioned above, for example substances which disturb the hormone system (endocrine disruptors).
How will REACH promote innovation and development of safer substitutes?
To enhance industry's competitiveness, one of the objectives of REACH is to promote research and development and innovation. For example:
- uses of substances in product or process-oriented R&D do not need to be registered for up to 5 years, renewable for a further maximum of 5 years in the case of a substance being exclusively used in the development of medicinal products or, under certain conditions, for a further maximum of ten years if the substance is not placed on the market.
the REACH threshold for registration (1 tonne/year) is much higher than the threshold of 10 kg for new substances under the previous regulatory system.
the costs of registering a new substance will be significantly lower than the cost of notification under the previous regulatory system.
registration will be quicker than notification, reducing the time to market.
the authorisation requirement for substances of very high concern will encourage companies to increase their research into safer substitutes.
Discrimination between new substances and existing substances will come to an end.
How much will REACH cost?
Testing and registration costs for producers and importers of chemicals: The Commission’s Impact Assessment in 2003 estimated the direct costs of REACH to the chemicals industry at a total of some €2.3 billion over an 11 year period.
Costs to downstream users: The costs to downstream users of chemicals were estimated in the Commission’s Impact Assessment of 2003 at €0.5 to 1.3 billion, under the assumption that 1 to 2 % of the substances would be withdrawn because continued production would no longer be profitable. Costs could rise to €1.7 – 2.9 billion when industry would face higher substitution costs in the downstream supply chains.
Total costs: Consequently, the overall costs of the Commission’s proposal of 2003 to the chemicals industry and its downstream users were estimated to be in the range of €2.8 - 5.2 billion. From a macroeconomic perspective, the overall impact in terms of a reduction in the EU’s Gross Domestic Product (GDP) was predicted to be very limited, whereas REACH will contribute to a marked improvement in health and environmental protection while safeguarding the competitiveness of industry. REACH will lead to significant public and private savings in health care and pollution control.
(general information on REACH)
(general information on REACH)
(European Chemicals Agency website)