What is the REACH Regulation?
The European Union’s (EU) REACH Regulation (EC 1907/2006) pertains to the Registration, Evaluation, Authorisation and Restriction of Chemicals. Implemented with the goal of protecting people and the environment from potentially harmful chemical substances, the REACH Regulation makes industry responsible for managing the risks of these substances in the market, and for providing the relevant safety information to users and consumers. It also prioritizes the progressive phase-out of some of the most dangerous chemicals in products once suitable alternatives are found.
What is an article under REACH?
Prior to a 2015 ruling by the Court of Justice of the European Union (CJEU), it was commonly understood that a complex article comprised of multiple parts was considered a single article in relation to compliance with REACH thresholds. Now, however, each component within a complex product is considered an article in itself. This ruling drastically changed the way companies apply REACH to their products, requiring importers to determine whether any single article within a product contains a substance of very high concern (SVHC) over the 0.1 percent weight by weight threshold. If so, the importer (along with each purchaser of that product or component) has supply chain communication requirements.
What are substances of very high concern under the REACH Regulation?
Substances of very high concern (SVHCs) are substances deemed to have serious or irreversible negative effects on human health and the environment. If a substance is identified as an SVHC, it may be added to the Candidate List for eventual inclusion in the Authorisation List (Annex XIV). Suppliers of articles containing SVHCs must provide the recipient of the article or the consumer with safety information about its use and composition if the substance is (a) found on the Candidate List and (b) present in a concentration above the threshold of 0.1 percent weight by weight per article.
Does the REACH SVHC threshold apply to packaging?
Yes, each level of packaging associated with a product is considered a separate article. For example, if each product is packed in styrofoam, which is then packed in an individual box, which is then packed in a larger box that is filled with bubble wrap, there are at least four (4) different articles in addition to the product. All of these must be assessed for compliance with the substances of very high concern (SVHC) threshold.
What is Registration under the REACH Regulation?
The REACH Regulation requires companies that manufacture or import chemical substances in quantities greater than one ton per year to collect information about the properties in these substances and assess the risks they pose. This information is communicated to the European Chemicals Agency (ECHA) using a registration dossier (a data submission prepared by a lead registrant or REACH consortium for a substance to be registered with the ECHA).
Who is required to register substances for REACH compliance?
Registration is required for individual substances, substances in mixtures and certain substances in articles manufactured in, or imported to, the European Union (EU) in quantities greater than one ton per year.
Those required to register substances include:
- EU manufacturers or importers of substances on their own or in mixtures
- EU producers or importers of articles meeting the criteria in the Guidance on Requirements for Substances in Articles
- An EU “only representative” appointed by a manufacturer, formulator or article producer that is outside the EU to fulfill the registration needs of importers
What is Evaluation under the REACH Regulation?
The European Chemicals Agency (ECHA) and European Union (EU) Member States evaluate the information submitted by companies within registration dossiers and testing proposals to determine whether the associated substances are safe for use. If a substance is deemed unsafe, risk management measures may be implemented, including restrictions, the identification and communication of substances of very high concern (SVHCs), or other actions outside the REACH Regulation itself.
What is Authorisation under REACH?
The Authorisation process ensures risks posed by substances of very high concern (SVHCs) currently in use are properly managed and progressively replaced by safer alternatives. This happens through a two-step regulatory process involving the Candidate List and the Authorisation List.
The Candidate List contains substances identified as being of very high concern to human and/or environmental health. Once added to the list, the use of these substances by companies manufacturing, importing or using them (as stand-alone substances, mixtures or in articles) in concentrations greater than the 0.1 percent weight by weight threshold are obliged to provide the recipient of the article or the consumer with necessary information about safe usage.
Substances on the Candidate are then considered for inclusion in the Authorisation List. Once on the Authorisation List, a substance cannot legally be placed on the European Union (EU) market, or used after its sunset date, unless a manufacturer, importer or downstream user is granted a specific authorisation for that use, or if the use is exempted from authorisation, as per Annex IV of the REACH Regulation.
How do I make an application for Authorisation under the REACH Regulation?
Manufacturers, importers and downstream users can apply for specific authorisation to place a substance present on the Authorisation List (a substance of very high concern, or SVHC) on the market, or to use it in production. An application must include, at minimum, a chemical safety report, an evaluation of any available alternatives to that substance, and a plan detailing the eventual replacement of that substance over time. Authorisations are granted if the applicant demonstrates the hazards of using the SVHC can be mitigated adequately.
What is Restriction under the REACH Regulation?
Restrictions are used under the REACH Regulation when the risks to environmental and human health from any given substance are deemed unacceptable. Restriction involves limits or bans on the manufacture, sale or use of that substance. Member States and the European Chemicals Agency (ECHA) can propose such restrictions, and anyone can comment on proposals in favor of particular restrictions (including interested companies, industry bodies and civil society).
How are restricted substances determined and enforced under REACH?
Final decisions on restrictions are made by the European Chemicals Agency (ECHA), Member States and relevant experts. Once a final restriction has been agreed upon, all manufacturers, importers, distributors and downstream users, including retailers, must comply. It is up to the authorities in each member state to govern enforcement.
A substance will also be moved from the Authorisation List to the Restricted List when there are no longer any existing authorisations in place for that substance.
How can manufacturers proactively demonstrate REACH compliance?
The majority of manufacturers use declarations to confirm compliance with REACH. Some manufacturers choose to provide chemical breakdowns — called Full Material Disclosures (FMDs) — of their products instead. It is up to the manufacturer to decide how this information is communicated to clients, given declaration content is not regulated under the REACH Regulation. However, conformity with declaration standards such as IPC-1752A is considered best practice. Assent’s FMDComplete tool helps manufacturers easily generate and manage FMDs.