What Is It?
REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) is a European Union (EU) regulation that has as its goal the protection of human health and the environment from the risks associated with the use of chemicals. The REACH Regulation went into effect on June 1, 2007 and has been described as the most complex created by the EU. It will affect industries worldwide and applies to all chemicals manufactured, used, or present in products in the EU. This may apply to as many as 143,000 substances. Believing that this only applies to the chemical industry is short sited. All products are made of chemicals. REACH can have both direct regulatory effects and indirect supply chain reporting requirements. The regulation shifts the burden of identifying hazards, means of mitigating hazards, and managing risk from government to business. To manage this regulation, the EU has established the European Chemicals Agency (ECHA).
This overview is meant only to provide the highlights. This is a huge regulation with much more complexity than can be included here. The REACH Regulation along with other resources can be found at the ECHA site.
Does This Apply to My Company?
As one of the most far reaching and comprehensive regulations, all companies will have to pay attention to REACH. If you are a manufacturer, you must pay attention to, among other things, the Substances of Very High Concern (SVHC), Authorization list (Annex 14), and Restrictions on Substances (Annex 17). Each of these will have some reporting or labeling requirements.
Manufacturers will need to have declarations in place for SVHC substances in their parts as well as safe handling instructions. When a substance reaches authorization, there are labeling requirements if an authorization for use is granted.
Distributors will have to be able to point their customers to the manufacturers’ declarations and will have to forward any labeling requirements.
Registration, Evaluation, Authorization, and Restriction
Registration is the process of identifying substances that are produced or used in the EU. It applies to substances directly as well as substances in mixtures and in articles (parts). There need be only 1 registration per substance even if used across many industries.
For substances in articles, a registration must be submitted if:
The substance is produced or imported at a weight greater than 1 ton per year
Has a mixture or concentration greater than 0.1% by weight
Meets requirements of Article 57.
Since the regulation has been in effect since 2007, most of the registrations have been completed.
The registration information must be detailed and complete with respect to substance testing, compliance proposals, and risk to human health and the environment. Evaluation may result in one of the following three actions:
- The registration may be in compliance and no further action required
- More information may be required
- A draft or final decision may be made
As a result of the actions in evaluation, a substance can start the process of being classified a Substance of Very High Concern (SVHC). This is a step on the path to Authorization (Annex 14). It can also move directly to Restriction (Annex 17). Article 59 governs the process for classification as an SVHC, while Articles 68 through 73 govern the process for a substance to be classified as Restricted (Annex 17).
Substances that meet the criteria of Article 57 are candidates for SVHC. Prior to inclusion on the SVHC list, there is a notice published and a 60 day comment period. New SVHC List substances are typically published in June and December. Once on the SVHC list, the substances may become candidates for Authorization.
AUTHORIZATION (Annex 14)
SVHC’s are prioritized to determine if they should be recommended for authorization. If a substance from the SVHC is recommended for Authorization, there is a 90 day comment period. Once the substance is added to the list (Annex 14) it cannot be used unless an authorization has been granted. The authorization has a time limit and further review.
RESTRICTIONS (Annex 17)
Restricted substances are banned or limited for use in the EU unless it complies with the restriction. Prior to any restrictions, there is a public comment period. These restricted substances and limitations are listed in Annex 17.
So What Does All This Really Mean to Me?
Some Things to Watch:
- Your company needs to know what’s in their products.
- Although most substances have been registered, you may want to check on yours.
- Authorization – Annex 14:
- Recommendation and Prioritization of SVHC substances for inclusion in Annex 14 (also public consultation site)
- Previous Recommendations/Prioritizations
- Authorization List (Annex 14) Current Applications for Authorization (exemptions)
- List of previous applications for Authorization (and results)
- Restrictions – Annex 17:
Some Actions Required
- There are opportunities to comment at several points in the process of classifying substances
- Once a substance is on the SVHC list, you must report (have a declaration) if you have any of the SVHC substances in your parts above 0.1% by weight.
- For an SVHC, you must have safe handling procedures available to send to customers.
- For substances on Annex 14 (Authorization) there are labeling requirements that must be met if an authorization for use is granted.
- There may be opportunities to redesign your parts with new substances.