Here is an overview of some important aspects of REACH that may affect YOU.
What is REACH?
Fundamentally, REACH shifts the burden-responsibility and costs-to the private sector, your business, to demonstrate that the chemicals you produce, use, and place on the market in large quantities are safe for humans and the environment. This is referred to as the “precautionary principle.”
In addition, the regulation:
- Replaces 40 separate pieces of legislation.
- Requires industry to (pre)register substances manufactured/imported at greater than or equal to 1 metric ton (mt) (about 2,200 lb) per year-No registration/data, no market. Your product will not get into the EU without registration.
- Applies to all substances whether manufactured, imported, used as intermediates, or placed on the EU market either on their own, in preparations, or in articles.
- Requires data sharing and cooperation among companies.
- Focuses on substances of very high concern (SVHC), which will likely result in some chemicals disappearing from the supply chain and others needing revised manufacturing processes.
- Establishes the European Chemicals Agency (ECHA).
REACH Applies to:
- Substances: any chemical element and its compounds-acetone, copper sulfate, etc.
- Preparations: mixtures or solutions of two or more substances-paints, adhesives, dyes, etc.
- Articles (products): items whose specific shape, surface, or design is more important than chemical composition-insulated wires, laptops, lamps, cars, erasers, etc.
Direct U.S. Impact
U.S. companies or any companies outside the EU are not directly regulated under REACH unless they have an EU-based subsidiary that meets the EU legal-entity requirements. U.S. companies without a subsidiary with a legal presence in the EU, however, are not able to (pre)register substances directly. Instead, they must either rely on their importer to register their substances or appoint an EU-based representative, an only representative (OR) under REACH, such as a consultancy or law firm with chemical expertise.
Companies that do not have a legal presence in the EU are permitted either option under REACH. However, appointing an OR versus relying on an importer allows you to have more control over the registration process, minimizes the risk of having disruptions if the importer does not meet the REACH requirements, and avoids the disclosure of potentially sensitive information to the importer.
Will It Reach You?
Here are a few straightforward examples where you could have REACH obligations:
- You export greater than or equal to 1 mt per year of substance directly to a customer in the EU.
- You sell a substance to a non-EU customer or distributor who exports greater than or equal to 1 mt per year of the substance to a customer in the EU.
- Your EU-based subsidiary buys directly from a non-EU supplier.
- You use materials produced in the EU.
- Registration: of existing and new chemical substances based on data (a dossier) and safety assessments. Data gathering requires communication up and down the supply chain.
- Evaluation: of the registration dossier by ECHA and authorities in EU member state countries. May result in requests for further testing.
- Authorization: of SVHCs before the chemicals can be used-SVHCs include carcinogens, mutagens, and reproductive toxins (CMRs), chemicals that are persistent, bioaccumulative, and toxic (PBTs and vPvB), and substances that have endocrine-disrupting properties.
- Restriction: of certain dangerous chemicals-total or partial ban or other restrictions for specific uses, based on an assessment of risks.
REACH Exemptions and Exclusions
Totally exempted from REACH:
- Radioactive substances, nonisolated intermediates, wastes, substances under customs supervision, substances necessary for the interests of defense
- Substances of Annex* IV (e.g., water, sugar)
- Substances of Annex V (e.g.., manufacturing by-products, certain substances occurring in nature)
- Polymers (although monomers need registration)
- Uses regulated by other legislations (e.g., drugs, foodstuffs, pesticides)
*Editor’s note: Annexes are attachments, including tables or lists, that flesh out REACH.