REACH is a new European Union legislation regarding registry, evaluation, licensing and prohibition of chemicals. Covering and uniting a series of EU legislations and statutes, REACH became effective as of 1 June 2007.
The main aims of REACH are:
- To ensure a high level of protection of human health and the environment from the risks that can be posed by chemicals
- To hold chemical producers and exporter/importers responsible for assessing and managing the risks posed by chemicals
- To ensure free circulation of substances in EU
- To enhance competitiveness and innovation in the EU chemistry industry
- To promote alternative methods for evaluation of hazardous qualities of substances. e.g. QSAR and read across.
No data, no market!
A significant step of REACH is to have substances registered at a central European Chemicals Agency by the producer and exporter/importer. A registry pack should be supported by a standard series of data regarding the substance. Amount of the data requested should be proportional to the amount of substance to be produced or presented.
If you do not have your substance registered, related data will not be available and therefore you cannot legally produce or market these products in EU. In other words, no data, no market!
Scope and exemptions
REACH is applied to substances produced or entering in EU markets in an amount of minimum 1 ton. In general, it is applied on all substances, either on their own, in a preparation or in an article (provided that the substance is expected to be emitted from the article during use under normal and clearly foreseeable conditions). Some substances are consciously left out of scope:
- Radioactive substances
- Substances under customs supervision
- Transported substances
- Non-isolated intermediates
- Some naturally-formed minor-hazardous substances
For some substances, precautions are applied within the scope of special laws:
- Medicinal products for people and animals
- Food or food additives
- Plant protection and biocidal products
Other substances requiring more special precautions in accordance with the REACH legislation, provided that they are to be used under certain circumstances:
- Isolated intermediates (On-site isolated intermediate)
- Substances used in Research & Development (Scientific Research and Development)
In the European market there were more than 100 thousand (estimated as 30 thousand before the pre-registration process) substances marketed in minimum amount of 1 ton per year. Registration of all of these substances in one go would be very difficult for both industries and regulatory bodies. To overcome this difficulty, three-phased registration was planned for products already being produced and marketed. With these phases, the fulfillment of registration obligation was extended to 2018. In order to benefit from these phase-in deadlines, producers or suppliers should have made pre-registration between the 1stJune 2008 and the 1stDecember 2008 or a later pre-registration under special conditions. Pre-registration is not a legal liability but it is recommended as it enables producers and suppliers to benefit from the transition periods.
This information is used to assess and control the risks and damage arising from the substance. This information and assessment has to be submitted to ECHA (European Chemicals Agency) in Helsinki, Finland.
You may find the list of laboratories performing physicochemical tests required for registration on the website of TÜRKAK-Turkish Accreditation Agency (by entering the name of the related test). Please make sure that the laboratory performs tests recognized by REACH. However, you should remember that ECHA requests GLP (Good Laboratory Practices) certification for some tests (e.g. ecotoxicology and toxicology).
Joint submission and data sharing
This principle is based upon the idea that data on the basic qualities of a substance can be shared by all companies producing or marketing this substance. Each company separately registers company information (e.g. company name, purpose of use, etc.). Companies reach a common ground on the sharing of information through the Substance Information Exchange Forum (SIEF). Details of the sharing are determined by companies. Companies making joint submission through SIEF benefit from discounts in registration fees.
Dossiers registered at REACH are evaluated in terms of the following:
Compliance check: This is the control phase for checking the data provided by the industry. ECHA in Helsinki shall perform this check on a sample percentage of those dossiers (no lower than 5% of the total) received by the Agency for each tonnage band.
Dossier Assessment: For substances registered at the highest tonnage level (above 100 tons per year), the registrant will make a proposal regarding the animal testing among standard tests. ECHA will review this proposal to avoid unnecessary animal testing.
Substance Assessment: This assessment is performed by Authorized Bodies of member countries for substances requiring regulatory actions due to their hazardous qualities. Among important regulatory consequences of the assessment is increasing limitations on the production, supply and use of substance. Substance assessment may also result in additions to the list of substances subject to permission or proposals to transfer data that require changes in classification and labeling or other precautions in line with legal requirements to other authorities.
All files will be checked to ensure completeness of data. This check is not related to the appropriateness or quality of data.
Industrialists to produce or market substances of “very high concern” have to apply for authorization. ECHA in Helsinki will issue the list of substances subject to authorization on 1 June 2009. (The 'Candidate list' was issued on 28 October 2008 and 7 substances of high priority are expected to be included in Annex XIV on 14 January.) Companies to market or use such substances have to apply to ECHA for authorization. Authorization decisions are taken by the European Commission. Applicants should prove that risks posed by the use of such substances can be efficiently controlled or that socioeconomic benefits are higher than the risks. Applicants should also investigate the existence of safer alternatives or technologies. If such options are available, they should make a substitution plan. If there are no alternatives, they should provide information on R&D operations (if any).
Any substance posing a certain threat can be restricted. Restrictions may be in various forms: from prohibition of public offering to complete ban. Restrictions can be applied to any substance, including those not requiring registration. This part of REACH replaces 76/769/EEC Directive.
Classification and Labelling
Being clearlyinformed on the potential dangers and risks of chemicals is an important part of chemical safety. Current system of the classification of various chemicals according to their characteristics (e.g. corrosive or toxic for fish, etc.) will also be used in REACH. A classification and labelling process in line with the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) was launched by the EU in late 2008 (CLP). REACH is prepared with reference to GHS.
Substances of Very High Concern
Some chemicals have carcinogenic (causing cancer), mutagenic (causing genetic mutation), reprotoxic (toxic effect on reproduction), persistent pollutant, bioaccumulating (accumulating in animal tissue) effects. These are substances of “very high concern”. This category also includes chemicals with equivalent risks, such as those “shredding the endocrinal system”. One of the aims of REACH is to keep such substances under control through authorization process and encourage the industry to replace these with safer substances.
Communication in the supply chain
One of the fundamental qualities of REACH is the communication of data on chemicals up and down the supply chain. All information available to producers or exporters in terms of controlling threats and risks posed by chemicals use should also be available and clear to users. REACH statute provides a framework for up and down distribution of such information in the supply chain. REACH is adapting the current system (Safety Data Sheet) for communication of data. This form should be included in the materials sent downstream in the supply chain and information on safe management of chemicals should be given to users. In time, these safety data sheets will also contain information on safe use and processing. For test that might be needed at this stage, you may find the list of laboratories on the website of TÜRKAK-Turkish Accreditation Agency. However we recommend that you ask your customer whether it will accept these tests or laboratories.