A Complete Guide to REACH - the Registration, Evaluation, Authorization, and Restriction of Chemicals
REACH – the Registration, Evaluation, Authorization, and Restriction of Chemicals – is a regulatory framework intended to protect human health and the environment from risks posed by exposure to chemical substances. Generally, REACH regulations apply to all chemical substances, including those used in industrial processes, the workplace, and everyday household items.
Several countries across the globe have enacted REACH regulations, but one of the first to be implemented was the European Union’s REACH (EC 1907/2006) in 2007. EU REACH is considered the standard for REACH compliance, sharing a similar purpose with REACH regulations in other countries. The primary difference between worldwide REACH regulations is data collection and reporting requirements.
This e-book will explore various REACH regulations around the globe. It will also provide general tips to simplify the REACH compliance process. Finally, it will explain how using Source Intelligence’s REACH compliance solution streamlines the supplier communication and data collection process.
Global REACH Regulations
While there are several REACH regulations globally, three countries have the most extensive programs: the European Union, the United Kingdom, and China. The EU’s REACH regulation is considered the most robust in the industry. These three regulations are explored in-depth below.
European Union (EU) REACH
EU REACH, enacted in 2007 and governed by the European Chemicals Agency (ECHA), is a regulation restricting the use of certain chemical substances in all parts and products manufactured, sold, and imported within the EU. The EU REACH regulation consists of four parts: registration, evaluation, authorization, and restrictions.
Registration
Companies are responsible for identifying the properties and uses of any substances manufactured or imported in quantities equal to or greater than one tonne per year. Companies must also assess the hazards associated with these substances and the potential risks they present. This information must then be shared with the ECHA through a registration dossier submission.
Registration dossiers contain substance hazard information, an assessment of the risks associated with the use of the substance, and an overview of how the risks should be managed. Registration dossiers are required for individual substances as well as substances in mixtures and, in some cases, articles. However, chemical substances already regulated under other legislations are exempt from REACH requirements.
Evaluation
The ECHA evaluates each submitted registration dossier. The evaluation consists of three components:- Compliance Check – The ECHA will check that the registration dossier includes all required information to comply with REACH
- Testing Proposal Assessment – The ECHA will review how the product will be tested and ensure that no unnecessary testing will take place, especially on animals.
- Substance Investigation – The ECHA may conduct a broader evaluation of select substances of concern.
If a registration dossier fails to meet the criteria of any of the three evaluation sections, it could be rejected and sent back to the submitting company for corrections.
Authorization
Authorization requirements ensure that risks from substances of very high concern (SVHCs) are properly controlled and gradually replaced by alternative substances or technologies. Annex XIV of the REACH regulation lists substances that are subject to authorization. Substances listed in Annex XIV cannot be placed on the market after a certain date (typically referred to as a sunset date). However, companies can be granted authorization for specific uses of certain substances.
Restrictions
EU countries or the European Commission (via the ECHA) can impose EU-wide restrictions on substances deemed to cause unacceptable risks to human health or the environment. Substance restrictions range from limited production to complete bans on use.
United Kingdom (UK) REACH
UK REACH, enacted on January 1, 2021, shares the same fundamental principles as EU REACH but operates independently. The regulation is governed by the UK government’s Health, Safety, and Environment (HSE) branch. It applies to the majority of chemical substances, either manufactured or imported within Great Britain (GB), which includes England, Scotland, and Wales.
Similar to EU REACH, UK REACH puts the burden of proving the safety of chemical substances on manufacturers and importers and – in most cases – apply to substances in quantities of one tonne or more per year. Chemical substances within the scope of UK REACH include the substance itself, a substance in a mixture, or a substance that makes up an article.
Certain substances are exempt from UK REACH, including:- Radioactive substances
- Substances under customs supervision
- Non-isolated intermediates
- Some naturally occurring low-hazard substances
- The transport of substances
- Waste
- Food and foodstuff additives
- Human and veterinary medicines
- Plant protection products and biocides
- Isolated intermediates
- Substances used for research and development
China REACH
China REACH, also referred to as MEE Order 12, was enacted on January 1, 2021, as the second revision of Measures for the Environmental Management Registration of New Chemical Substances. It is governed by the Ministry of Ecology and Environment (MEE).
China REACH requires companies to submit notifications (similar to the EU REACH registration dossier) for new chemical substances manufactured or imported within China that are not currently listed in the Inventory of Existing Chemical Substances in China (IECSC) or existing listed chemicals subject to new use management. The IECSC consists of public and confidential substances. Companies must submit a formal request to view the list of confidential substances.
The following entities must submit notifications for new chemical substances:- Chinese manufacturers or importers
- Chinese processing users
- Overseas applicants via a Chinese agent (OR) with a legal entity in China
- Regular notification: >=10t/y new substances
- Simplified notification: 1-10t/y new substances (Under MEP order 7, even 1-10t/y requires regular notifications).
- Record filling notification: <1t/y new substance, polymer meeting 2% rule, and polymer of lower concern (Under MEP order 7, polymers of low
Notifications are reviewed by the MEE and then forwarded to The Ministry of Environmental Protection (MEP) for final approval. Record filling notifications do not require approval from MEP. Production, import, or use of these substances are admissible after the necessary information and documents are submitted. Simplified and regular notifications require test data submission.
Expand your global REACH knowledge
You’ve just explored how REACH works in the EU, UK, and China. Next are sections on additional global REACH regulations, common compliance challenges, and an in-depth look at Source Intelligence’s Global REACH solution.
Read the complete e-book for a deeper understanding of worldwide REACH compliance.