Guidance on EU REACH Regulation

Overview of REACH Regulation

The EU Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation came into effect on June 1, 2007, and was implemented on June 1, 2008.

According to REACH regulation, enterprises are required to submit registration to ECHA for chemical substances (whether the substance itself, substances in mixtures, or substances intentionally released in items) with an annual production or import volume exceeding 1 ton within the EU. Otherwise, the enterprise will not be allowed to continue manufacturing, importing or selling this chemical within the EU. In addition, for some registered substances, the regulations also stipulate that the obligations of assessment, notification/authorization, and restriction need to be fulfilled continuously.

The implementation of this regulation has severely affected the export of EU products, particularly in industries such as chemicals, machinery and electronics, textiles, dyeing, rubber, plastics, toys, and furniture.

Registration

Registration is the primary obligation under REACH regulation. After an enterprise successfully submits the registration dossier for a chemical substance to the ECHA, it will receive a registration number consisting of 18 digits.

After May 31, 2018, non-EU manufacturers or EU importers on the same supply chain who fail to complete registration before export/import (with an export volume exceeding 1 ton per year) will not be allowed to continue placing the corresponding products on the EU market.

Scope of Registered Substances

• Chemical substances released onto the EU market in quantities exceeding 1 ton per year
• Chemical substance components in mixtures released onto the EU market in quantities exceeding 1 ton per year
• Chemical substances intentionally released in items released into the EU market, with a total quantity exceeding 1 ton per year

The intentionally released substances in items refer to substances that are intentionally released from the items under normal or reasonably foreseeable usage conditions. Usually, they are released to achieve a certain auxiliary function of the item, such as fragrance substances in rubber, etc.

Registration Entity

• Producers of substances, mixtures, and articles within the EU
• Importers of substances, mixtures, and articles within the EU
• Non-EU producers of substances, mixtures, and articles: Must fulfill registration obligations through an OR within the EU

Registration Schedule

• ≥1000 tons/year, or high concern substances (CMR ≥1 tons/year, aquatic toxicity R50/53 ≥100 tons/year): by November 30, 2010
• 100-1000 tons/year: by May 31, 2013
• 1-100 tons/year: by May 31, 2018

Registration Process

1. The enterprise fills out a substance information questionnaire.

2. Material analysis, material inquiry

1) If there is an existing lead registrant (LR): Purchase the letter of access

2) If there is no LR: Data analysis, select LR, collect data

3. Case file preparation

4. Submission method

1) Regular joint submission

2) Opt-out submission (choosing not to participate in the joint submission)

5. Complete registration

6. Registration number maintenance

Assessment

Assessment is one of the core elements of the REACH regulation, carried out by ECHA and the competent authorities of member states, and includes:

• Dossier evaluation
• Substance evaluation

Dossier Assessment

• The review of testing proposals for certain endpoints that have been submitted under REACH high-tonnage registration, including Annex IX and Annex X.
• Conformity assessment involves ECHA reviewing the submitted dossier, which includes data quality and sources, reasoning for the argument, quality of the risk assessment report, etc.

After the dossier assessment, the applicant may be required to conduct additional tests and update the dossier and the risk assessment report.

Material Assessment

After REACH registration is completed, the competent authorities of the European member states will also conduct a material assessment. ECHA will issue the CoRAP, selecting substances that may pose risks to human health or the environment.

The selection of CoRAP substances is mainly based on the properties of the substances, especially persistence, bioaccumulation and toxicity. The content includes endocrine disruption, carcinogenicity, teratogenicity and reproductive toxicity, etc., and also takes into account the circulation and usage of the substances.

All substances on the CoRAP list will be assigned to different EU member states for assessment. The assessment member states will actively communicate with the registrants corresponding to the substances and will require enterprises to obtain and submit more information to comprehensively grasp the information of the assessed substances and thereby clearly identify the risks of the substances and promote the safe management of the substances.

Authorization

The REACH regulation holds that merely registering and evaluating products cannot address all the risks associated with chemicals. Therefore, in Annex XIV, it has established strict authorization systems for the use of certain chemicals.

The substances included in the authorization list can only be produced, imported or used after being authorized by the European Commission. Even if the annual production or import volume of these substances does not exceed 1 ton, authorization is still required.

These chemical substances are referred to as substances of very high concern (SVHC) and include those identified in accordance with Annex XIII:

• Under the current EU CLP regulations, those classified as 1A or 1B categories in the CMR (carcinogenic, mutagenic, and reproductive toxic) list;
• Persistent, bioaccumulative, toxic substances (PBTs) and substances with high persistence and high bioaccumulation (vPvBs);
• Substances that receive the same level of attention as CMR, PBT, and vPvB.

As of now, a total of 59 substances have been included in the list of authorized substances in Annex XIV, and production, import and use of these substances require authorization.

The purpose of the authorization procedure is to ensure the smooth operation of the internal market, to ensure that the risks of high-risk substances are fully controlled and gradually replaced, and when it is technically feasible and when alternative substances or technologies can replace them.

To achieve the goal, all stakeholders involved in the application for authorization, importers and downstream users should analyze whether there are alternative substances or technologies, and consider the risks, technical and economic characteristics of the alternative substances.

Restriction

REACH regulation also stipulates restriction procedures.

• If the production, use or placement on the market of a substance may pose uncontrollable risks to human health or the environment, the European Commission may include the substance on the restricted list (Appendix XVII).
• The current list of restrictions includes 74 items, mainly concerning CMR, PBT, and vPvB substances.

Latest Revision (April 3, 2025)

The European Commission presented the latest revised plan at the CARACAL meeting. The key points are summarized as follows.

• The validity period of chemical registration is 10 years. ECHA has the right to revoke registration numbers that have not been updated or do not meet the requirements.
• Strengthen the management of SVHC and require more substances to be reclassified.
• Promote the digitalization of supply chain data, including digital security data sheets (e-SDS) and product digital passports (DPP).
• Enhance the power of the EU to conduct audits and supervision of its member states.
• Update Appendix III, X, XI, etc., and uniformly update the requirements for assessment and restrictions.
• Introduce the mixture assessment factor (MAF).
• Establish new regulatory tools such as the General Regulatory Approach (GRA).

Disclaimer: The above content is compiled based on existing public information and is for reference only.

Our Services

The wide applicability of REACH regulation makes it a common challenge across multiple industries. Proregulations deeply understands the core of the EU REACH regulation and continuously monitors the dynamics of regulations such as the SVHC list, accurately predicting and proactively avoiding potential risks for clients.

• Regulatory interpretation and consultation
• REACH regulation training
• Chemical registration pathway planning
• Gap analysis
• Document preparation, pre-review and submission
• EU OR
• Risk management
• Assistance in communication with ECHA

Proregulations offers professional, efficient and cost-effective one-stop REACH solutions, enabling us to precisely manage the process for our clients. It helps you transform compliance burdens into competitive advantages, ensuring the smooth passage of your products through the EU. If you are interested in our services, please contact us.

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