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Understanding REACH on a Global Scale

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A Complete Guide to REACH Compliance

Download the e-book for a practical roadmap to understanding REACH requirements across global markets.

You’ll get a clear look at how global markets structure their REACH frameworks, where their obligations differ, and how those differences affect data collection, supplier engagement, and product reporting. The e-book also explains how to determine applicability, navigate exemptions and tailored provisions, and prepare for rising scrutiny around chemical safety—plus actionable steps to streamline REACH compliance and reduce manual work.

Introduction

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.  

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.  

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
Other substances have tailored provisions under UK REACH, including: 

  • 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
There are three types of notifications under China REACH: 

  • 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.

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