BY GRAPHIC PRODUCTS STAFF
REACH is an acronym for Registration, Evaluation, Authorization and restriction of Chemicals.
REACH is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.
Introduction to REACH
The purpose of REACH is to provide a system that protects human health and the environment, while also providing a means for chemicals and other substances to freely move within the EU, Iceland, Lichtenstein, and Norway. REACH is administered, and compliance is monitored, by the European Chemicals Agency (ECHA) in Helsinki, Finland.
The requirements of REACH apply to all chemical substances, including those used in industrial processes, as well as consumer products. This means REACH applies to all solvents, paints, fuels, electronic devices, electrical equipment and appliances, and even clothing.
REACH requires all organizations that manufacture, or import chemical substances into the EU to register those substances. Registration can be done online through the IUCLID website.
The ECHA evaluates each registration for compliance with REACH. As a part of the evaluation, an ECHA scientific committee may study the substance to evaluate the risks it presents, and whether those risks can be managed. The ECHA may decide that the use of the substance must be restricted, or that prior authorization is required to use the substance. In addition, countries within the EU may also evaluate the substances to determine if they have any concerns.
There are some chemical substances that are exempt from the REACH registration requirements. These include chemical substances:
- that are imported or manufactured in quantities below 1 metric ton;
- for use in research and development;
- that are wastes;
- that are used in ways covered by other EU legislation, such as medicine and food products;
- that are pesticides or biocides;
- that are polymers (however, monomers included in polymers must be registered);
- manufactured or imported by companies that had notified chemical substances under previous EU Directive 67/548/EEC.
Other substances, listed in Annexes IV and V of the REACH regulation, are exempt if they have not been modified. These include:
- cement clinkers
- crude oil
- coal and coke
The REACH requirements for registration are being phased in, over an eight year period. The deadlines are based on the quantity manufactured or imported. The dates are:
- 1,000 tonnes or more annually – December 1, 2010
- 100 tonnes annually – June 1, 2013
- 1 tonne annually – June 1, 2018
In addition, some highly toxic chemicals were required to be registered by December 1, 2010, without regard to quantity. Substances that are released to the environment under normal conditions must also be registered.
Who is Responsible for Compliance?
Companies are responsible for ensuring the products they sell are in compliance with REACH. This means they must work with their “upstream” suppliers and “downstream” customers. They need to ensure the substances and materials they purchase are registered, and know the hazards and control measures associated with those substances and materials. They must then register the products they produce and pass that information on to their customers, ensuring that their immediate customers have all needed information to be in compliance with REACH, as well as to pass on to any future customers.
Manufacturing paint provides a simple example. The paint manufacturer purchases pigments and other ingredient chemicals, which must be registered with the ECHA. The suppliers of those chemicals are responsible for the registration, and for providing a Safety Data Sheet (SDS) with accurate and complete information to the paint manufacturer. The paint manufacturer must then supply their customers with a SDS for the paint.
Customers also have responsibilities under REACH. They must:
- Use the risk management measures specified on the Safety Data Sheets for the substances they use.
- Inform their suppliers about how the substances will be used.
- Supply their own customers with an SDS for the products they make.
Companies Outside the EU
Companies outside the EU have no direct responsibilities under REACH. It is the responsibility of the importer, who brings the substance into the EU, to pre-register or register the substance. However, non-EU companies exporting to the EU should be aware of the REACH requirements.
Substances that have been designated by the EU as a “substance of very high concern” (SVHC) must have use-authorization before being imported. As a business practice, then, non-EU companies must ensure that use-authorization has been obtained before shipping the substance to the EU. Otherwise, the shipment may be returned. SVHCs are defined by the ECHA as those substances:
- Meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction category 1A or 1B in accordance with Commission Regulation (EC) No 1272/2008 (CMR substances).
- Which are persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to REACH (Annex XIII).
- Identified on a case-by-case basis, for which there is scientific evidence of probable serious effects on an equivalent level of concern with CMR or PBT/vPvB substances.
SVHCs may be authorized for use in the EU, but, depending on the substance, they may not be sold or used after a specified date without either an authorization or an exemption for a specific use.
Non-EU companies that wish to determine whether a product requires an authorization can check the “authorization list” (REACH Annex XIV). There is also a “candidate list” identifying those substances currently being considered for use-authorization requirements.
Understanding and complying with REACH can be complex. To help companies comply with the requirements of REACH, there is a helpful online resource. The Navigator is a tool that can assist in clarifying your role under REACH, identify your obligations, and help you find relevant guidance documents, manuals, legislation, and other information. However, keep in mind that the Navigator is just an online tool. It can only provide generic information. It does not solve specific problems, such as classifying a particular substance.