EU REACH

1 Overview

The Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (a.k.a “EU REACH”) came into force on 1 Jun 2007, establishing a uniform system for the control and safe use of chemicals that are manufactured in, or imported into, the EU. Following the introduction of EU REACH, all chemical substances on their own or in mixtures or articles can be managed by prescribing the requirements for registration, evaluation, notification/authorisation, restriction, and extended safety data sheet (eSDS).

The revision of EU REACH is a key component of the Chemicals Strategy for Sustainability (CSS) presented in 2020. The revision proposal would consider options, including revising registration requirements; introducing a mixtures assessment factor; simplifying communication in the supply chains; revising the provisions for dossier and substance evaluation; reforming the authorisation process; reforming the restriction process; and revising provisions for control and enforcement. However, the EU Commission failed to adopt its proposal by the fourth quarter of 2023. Currently, it remains uncertain when this revision will be presented.

The core contents under the EU REACH can be summarized as follows:

1. Four Obligations: Registration, Evaluation, Notification/Authorisation, Restriction, and eSDS

2. Three Chemical Objects: A substance, on its own, in a mixture or in an article

3. Four Major Roles: EU Manufacturers, EU Importers, Companies acting as Only Representatives (for non-EU manufacturers), Downstream Users

4. Three Administrative Tools: REACH-IT for information communication, IUCLID for creating dossier, Chesar

2 Management Framework

The chart below is a conceptual representation of the EU REACH framework.

Fig. 1 - Flow Chart Summarizing EU REACH’s Regulatory Framework for Chemicals

3 How to comply

EU manufacturers, importers or downstream users of chemical substances to be used on their own, in preparations and/or to produce articles have legal obligations to comply with EU REACH.

3.1 Registration

With a “no data, no market” principle, non-registered substances must not be manufactured, imported, placed on the market, or used on their own, in mixtures or in articles in the EU.

3.1.1 Registration Scope

Applicable Scope

Registration shall apply to any of the following conditions under EU REACH:

• Substance on its own, Manufacture/Import ≥ 1 t/a;

• Substance in a mixture, Manufacture/Import ≥ 1 t/a;

• Substance intended to release in an article, Manufacture/Import > 1 t/a;

• Polymer consists of 2% weight by weight (w/w) or more of such monomer substance(s) or other substance(s) (the total quantity ≥ 1 t/a);

• On-site isolated intermediates, Manufacture/Import ≥ 1 t/a.

Note: The release of a substance from an article is deliberately planned and has a specific function in the use of the article. This is frequently not the main but an accessory function of the object, such as air freshener.

Registration does not apply to the following:

• Food or feeding stuffs

• Medicinal products

Substances exempted from registration are the following:

• Substances included in Annex IV of EU REACH

• Substances covered by Annex V of EU REACH

• Recovered substance already registered

• Re-imported substance

• Polymers (except for some polymers under certain conditions)

• Substances used in product and process orientated research and development (PPORD)

3.1.2 Registration Bodies

• Manufacturers and importers of substances, mixtures, article in EU;

• Non-EU manufacturers can export to the European Union through two different routes under EU REACH: either via an importer who has registered the substance or by appointing an Only Representative (OR).

3.1.3 Registration Timeline

Note: Phase-in substances are the so-called “existing substances”, these are either listed in the EINECS or NLP list, or the substance manufactured without being placed on the EU market after 31 May 1992. All substances that do not fulfill any of the criteria for phase-in substances are considered to be non phase-in substances.

3.1.4 Regular Registration Procedure

3.1.5 Standard Information Requirements

The registration dossier is the set of information submitted electronically via REACH-IT by a registrant for a particular substance. It consists of two main components including (1) a technical dossier and (2) a chemical safety report which is required if the registrant manufactures or imports a substance in quantities of 10 tonnes or more per year.

If you are preparing a dossier as the only registrant for that substance, and no joint submission exists, you need to provide all the information in your own dossier.

For joint registration, registrants of the same substance have to share data and submit information on intrinsic properties of that substance jointly to ECHA, with a lead registrant first submitting the “jointly submitted dossier” on behalf of the other registrants before others can submit their own member dossier as a part of the joint registration. The table below shows the information  submitted by the lead registrant for the group (joint information) and the information submitted by each registrant separately (individual information).

3.2 Evaluation

3.2.1 Substance Evaluation

The information submitted by registrants is evaluated by ECHA and the Member States in order to examine the quality of the registration dossiers and the testing proposals and to clarify if a given substance constitutes a risk to human health or the environment.

Evaluation under REACH focuses on three different areas:

• Compliance check of registration dossiers submitted by registrants

• Examination of testing proposals submitted by registrants

• Substance evaluation

As a result, the registrant may need to update their registration dossier and decide on whether to proceed with more tests and evaluations.

3.2.2 Community Rolling Action Plan

The Community rolling action plan (CoRAP) prioritises substances for evaluation over a period of three years. If a substance is on the CoRAP list, it means that a Member State has evaluated or will evaluate it over the coming years.

The evaluation may in the end conclude that the risks are sufficiently under control with the measures already in place. Otherwise, it may lead to the proposal of EU-wide risk management measures such as restrictions, identification of substances of very high concern or other actions outside the scope of REACH e.g. harmonised classification.

Normally, ECHA updates the plan annually in March. Below are the latest updates:

• CoRAP update covering the years 2023, 2024 and 2025;

• CoRAP update covering the years 2024, 2025 and 2026.

3.3 Authorisation

3.3.1 Authorisation Process

Authorisation is a process under REACH designed to manage the risks of hazardous substances. The aim of the authorisation process is to:

• Ensure that the risks related to substances of very high concern (SVHCs) are properly controlled throughout their life cycle;

• Promote the progressive replacement of SVHCs by suitable alternatives, where technically and economically feasible alternatives are available.

The authorisation process can be seen as a three-phase process:

Fig. 2 - 3 Phases of the Authorisation Process

3.3.2 SVHC List Obligations

The first step in the Authorisation process is the identification of a substance as a SVHC. The SVHC identification process includes a 45-day consultation. Substances with the following hazard properties may be identified as SVHCs:

• Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B in accordance with the CLP Regulation;

• Substances which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to REACH Annex XIII;

• Substances on a case-by-case basis, that cause an equivalent level of concern as CMR or PBT/vPvB substances.

Companies may have legal obligations arising from the inclusion of substances in the Candidate List of substances of very high concern (SVHC). These obligations, which are effective from the date of inclusion, refer not only to the listed substances on their own or in mixtures but also to their presence in articles.

• Safety Data Sheet for substances on their own and substances in mixtures

• Notification to ECHA for SVHC in articles

• Duty to communicate safe use information or respond to customer requests

Producers and importers have to notify to ECHA the substances listed on the Candidate List which are present in their articles, if both the following conditions are met:

• The substance is present in their relevant articles above a concentration of 0.1% weight by weight;

• The substance is present in these relevant articles in quantities totalling over one tonne per year.

Exemptions: There are two cases where notification is not required.

• The producer or importer of an article can exclude the exposure of humans and the environment to the substance during normal or reasonably foreseeable conditions of use of the article, including its disposal. In these cases, the producers and importers will give appropriate instructions to the recipient of the article;

• The substance has already been registered by a manufacturer or importer in the EU for that use.

Deadline: Companies have to notify no later than six months after the inclusion of the substance in the Candidate List.

Latest Updates: The Candidate List now contains 241 entries for chemicals that can harm people or the environment. On August 30, 2024, ECHA proposed adding six new chemicals to the Candidate List for eventual inclusion in the Authorisation List. The consultation period will close on October 14, 2024.

3.3.3 Application for Authorisation

ECHA has the legal obligation to regularly recommend substances from the Candidate List for the EU Commission to include in the Authorisation List. The prioritisation is based on information on the (1) intrinsic properties, (2) wide dispersive use or (3) high volumes that fall within the scope of the authorisation requirement.

Once a substance is included in the Authorisation List (Annex XIV), producer, importer or downstream users need to apply for authorization before the latest application date (if authorisation is not submitted before this date, a grace period applies) to continue using or placing it on the EEA market. Without authorization, its use or placement will be banned after given sunset date (placement on the market is stopped until authorisation is obtained).

Latest Updates: On February 7, 2024, ECHA released a draft 12th recommendation to the European Commission, which recommends the inclusion of 5 substances to the Authorisation List. The consultations were open until May 7, 2024. The Authorisation List now contains 59 entries.

How to apply for authorisation

Manufacturers, importers, only representatives or downstream users who wish to continue to place on the market and/or use such substances after their sunset date can apply for an authorisation for specific use(s) of the substance and submit it to ECHA.

The following is the information required in an application.

• Use description;

• Chemical Safety Report (CSR);

• Analysis of Alternatives (AoA);

• Socio-economic Analysis (not mandatory when the risks from a substance are adequately controlled); and

• Substitution plan (if suitable alternatives are available in the EU).

3.4 Restriction

Once the restriction has been adopted, manufacturers, importers (including importers of articles), distributors, downstream users and retailers must comply. At present, 73 substances/entries have been included in the Restriction List. Substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), categories 1A and 1B on their own, in mixtures or in articles that could be used by consumers may be added to the Restriction List (Annex XVII).

3.4.1 Scope and Exemptions

Restrictions under REACH Annex XVII are normally used to limit or ban the manufacture, placing on the market (including imports) or use of any substance on its own,in a mixture or in an article. Relevant stakeholders can signal their interest and express their views and concerns in the preparatory phase and public consultation phase of the restriction proposal submitted by EU Member States.

Restrictions are not applicable to:

• On-site isolated intermediates;

• Substances used in scientific research and development; and

• Substances only posing risks to human health from their use in cosmetics.

3.4.2 Ongoing Work on Future Restrictions

Launched on 25 April 2022, the Restrictions Roadmap sets out the planned restrictions, allowing companies to anticipate (potential) upcoming restrictions, e.g. by beginning substitution. It includes a rolling list of substances earmarked for restriction that will be regularly reviewed and annually updated.

The Rolling List is divided into two pools as below.

• Pool 0^(*): Substances already included in the Registry of Intention (RoI) for restrictions or where the Commission has requested ECHA to prepare a restriction dossier;

* A majority of Pool 0 substances were already subject to restriction procedures before the Roadmap was announced.

• Pool 1: Substances for which work is advanced and are under consideration by ECHA, Member States, or the Commission for restriction.

Latest Updates: The first update to the Roadmap happened on July 1, 2024 (click here to know more details).

4 Resources

News

• Sep 6, 2024 Latest Updates in European Chemicals Management

• Jun 28, 2024 ECHA Adds One Hazardous Chemical to SVHC List

• Mar 7, 2024 ECHA Consults on Adding 2 Substances to SVHC List

• Jan 24, 2024 ECHA Adds 5 Hazardous Chemicals to SVHC List

• Feb 19, 2024 ECHA Consults on Recommending Five Substances for Authorisation List

• May 9, 2024 Restriction Proposal on Chromium (VI) to Cover More Substances

• May 24, 2024 EU Enhances Restriction on the Use of Silicone D4, D5 and D6

Regulatory Database

• Consolidated version of the REACH Regulation

• Candidate List of substances of very high concern for Authorisation

• List of Substances Subject to Authorisation (Annex XIV of the REACH Regulation)

• List of Restricted Substances under REACH Annex XVII

• Community rolling action plan update covering the years 2023, 2024 and 2025

• Community Rolling Action Plan (CoRAP) update covering the years 2024, 2025 and 2026