Implementation of REACH – brief overview
The major task of producers and importers of chemicals is to evaluate these chemicals and register them with ECHA. Registration of all chemicals occurs in three stages. The first stage ended in November 2010, the second runs until November 2013, and the third will end in mid-2018.
It is the responsibility of the competent authorities to check the registrations. Five per cent of all registration dossiers are reviewed for quality. The competent authorities also assess certain chemicals with regard to properties of very high concern and for their risks to humans or the environment.
Authorisation and Restriction
With the exception of some chemicals (e.g. pesticides), there is no general obligation in the EU to obtain authorisation for the use of chemicals. REACH requires authorisation of so-called Substances of Very High Concern, or SVHC. The obligation of authorisation is intended primarily as a general prohibition of use. Upon request, the ECHA may grant authorisation, which requires the applicant to prove that the risks of the substance can be controlled or that the socio-economic benefit of its use is greater than the associated risk. It is also possible for the production, marketing or application of a chemical to be prohibited or limited by means of a restriction.
Implementation of REACH – in detail
The European Chemicals Regulation EC 1907/2006 concerns the registration, evaluation, authorisation and restriction of chemicals within the EU. REACH also makes provisions on the communication of information within the supply chain. The European Commission, the European Chemicals Agency (ECHA) in Helsinki as the central responsible authority, and EU Member States report regularly on progress. The first major review of REACH takes place in 2012.
Chemical substances may only be produced or marketed in the EU if they are registered under REACH (‘No data, no market‘). This basic principle issues from the experience gained under prior legislation under which no systematic data were available on virtually all chemicals. Manufacturers and importers must now disclose and submit information upon registration. This information must enable an assessment of the chemical concerned and include data on its uses, persistence in the environment, ability to bioaccumulate and its toxicity.
The registration requirements vary according to the volume of the produced or imported substance. If that volume amounts to ten tonnes per year, the manufacturer/importer must carry out his own risk assessment and disclose the results of this procedure. Depending on how hazardous the chemical is or what volume is concerned, different deadlines in the registration process apply. All chemicals will be registered on the EU market by 1 June 2018. Special regulations apply for the registration and notification of chemicals in articles.
Most of the information in registration documentation is available to the public and is accessible through the ECHA website, with the exception of information that classifies as trade and business secrets.
ECHA reviews all registration dossiers for completeness. It reviews another five per cent of registrations for compliance with the requirements of registration. So-called substance evaluations are carried out by the EU Member States: they evaluate the registration documentation of select substances as well as the companies’ own assessments. The results of a substance evaluation may require the submission of additional information or conclude that the substance should be subjected to an authorisation or restriction procedure. It may also determine further action is required in accordance with other existing legal instruments. The Community Rolling Action Plan, CoRAP List of Substances to be evaluated is updated every year. You can find it on the ECHA website.
Authorisation and Restriction
The competent authorities may identify certain chemicals to be “Substances of Very High Concern” (SVHC) after a formal assessment procedure.
To classify as SVHC the chemical must display one or more of the following properties:
- carcinogenic, mutagenic or toxic to reproduction or
- toxic and persistent in the environment and proven to bioaccumulate or
- very persistent in the environment and highly bioaccumulative or
- have similar characteristics that give rise for concern (e.g. endocrine disrupting effects).
REACH places Substances of Very High Concern on a Candidate List. The EU Commission prioritises chemicals from the Candidate List for authorisation. A date is set after which these substances may only be used in applications for which the ECHA has issued authorisation. Authorisation is issued for a limited time. The ultimate goal is to substitute these substances with less problematic chemicals.
Restriction is another means of chemicals regulation under REACH. Restrictions can act to limit or ban the manufacture, placing on the market or use of certain substances. In contrast to authorisation, restriction does not necessarily apply to a Substance of Very High Concern. A restriction may be issued if the manufacture, placing on the market or use of a chemical substance poses an unacceptable risk to human health or the environment that must be addressed by the European community. Restrictions can also become necessary if the chemicals in question might enter the EU in imported products.
Decisions on authorisation and restriction also take into consideration socio-economic impact as well as the potential impact of chemical substitutes.
Other provisions under REACH
Communication of information along the supply chain
Information on all chemical substances must be communicated along the entire supply chain; that is, from manufacturer or importer to downstream user and distributor, through to the retailer. This especially concerns all the information available that is necessary to guarantee safe handling of the substance. Information on hazardous substances is supplied in standardised form in so-called safety data sheets.
Substances in articles
In the REACH Regulation an article is “an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition”. If a Substance of Very High Concern is present in articles above a concentration of 0.1% (w/w), this information must be communicated to the recipient by every supplier in the supply chain. Consumers are also entitled to this information upon request.
Provisions on animal welfare
Animal welfare is an important consideration in REACH. Animal welfare organisations participated in shaping the provisions of the regulation. Unfortunately, alternative methods to replace animal testing entirely are not yet available. REACH stresses that animal testing may only be undertaken as a last resort and that alternative methods must be promoted. Registrants must determine prior to registration if studies exist and must make joint use of them. If studies on animal testing on vertebrates are available and are no more than 12 years old, they may not be repeated. Authorisation for testing on vertebrates must be granted by the European Chemicals Agency ECHA before testing is allowed. As a first step, testing proposals are announced and third-party information is collected. Subsequently ECHA takes a decision whether and under what conditions the testing is to be done.