An Essential Guide to the REACH Regulation in the EU

Are you a manufacturer or importer interested in placing consumer products in the EU market? Most consumer products have to comply with the REACH regulation.

Complying with the regulation may involve observing specific labelling, testing, registration, and documentation requirements. In this article, we cover the regulation’s applications and its requirements and address common questions associated with the topic. The European Chemicals Agency (ECHA)’s official site is used as a source in this article.

Related Articles

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REACH Annex XVII Substances List: An Overview

REACH SVHC Substance List: An Overview

REACH Product Lab Testing: A Complete Guide

What is the REACH regulation?

The Regulation (EC) No 1907/2006 concerning the registration, evaluation, authorisation and restriction of chemicals (REACH) is a legislative instrument that regulates chemicals that are manufactured and used in the EU.

Underpinning the regulatory provisions is the “precautionary principle”. The principle is a risk management approach that dictates that if a given policy or course of action would cause harm to the public, then it should not be carried out.

Thus, REACH compels manufacturers and importers to ensure that chemicals manufactured or imported are safe before being introduced to the market via stages elaborated upon in subsequent sections below.

Additionally, REACH provisions achieve the following:

a. Promoting other alternatives to animal testing

b. Creating a single market for chemicals

c. Fostering innovation and competitiveness in the sector

d. Establishing the European Chemicals Agency (ECHA)

Product scope

REACH applies to most chemicals that are manufactured, imported, or sold, and used on their own, in mixtures, or in products. Such chemical substances can be found in product categories such as the following:

• Food contact materials
• Electronic products
• Toys
• Furniture products
• Clothing apparel
• Footwear
• Cleaning products

Registration

Manufacturers and importers are obliged to register the chemicals that they employ for manufacturing or importing purposes in quantities of 1 tonne or more per year.

Manufacturers and importers of articles may have to register substances contained therein if the substance is:

a. Present in those articles in quantities totalling over 1 tonne or more per year; and

b. Is intended to be released under normal or reasonably foreseeable conditions of use

Information to be submitted for registration

The information required to be submitted for general registration purposes includes the following information:

a. A technical dossier that includes the information contained in article 10(a) of REACH; and

b. A chemical safety report (if required under article 14)

The Technical Dossier

The Technical Dossier contains some of the following:

a. Manufacturer or importer identity

b. Substance identity

c. Classification and labelling of the substance

d. Guidance on the safe use of the substance

e. Proposals for testing

f. Exposure information

What constitutes the technical dossier might differ from registrant to registrant as the information to be submitted may be different depending on certain factors (like the tonnage of substances manufactured or importers for example).

The chemical safety report

According to article 14 of REACH, if one imports or manufactures substances subject to registration requirements in quantities of 10 tonnes or more per year, then a chemical safety report documenting the chemical safety assessment needs to be submitted for registration purposes.

Evaluation

REACH has provisions that place responsibilities on member states and the ECHA. Under such provisions, the ECHA assesses whether the registrations are complying with the REACH requirements.

Evaluation by the member states and ECHA involves some of the following activities:

a. Examination of submitted testing proposals

b. Compliance check of the submitted technical dossiers

c. Substance evaluation

Post evaluation, registrants may have to submit further information relating to the substance.

Authorisation

In line with the intention behind the regulation, REACH contains a procedure that aims to:

a. Control the risks posed by substances of very high concern (SVHCs)

b. To progressively replace SVHCs with suitable alternative substances or technologies which are economically and technically viable

To achieve the above aims, manufacturers and importers are required to assess whether their product is or contains an SVHC. If yes, then they should consider whether it requires authorisation or whether it can be exempted.

How substances are included in the authorisation list

A substance with certain hazardous properties (like those classified as carcinogenic, mutagenic or toxic for reproduction) may be identified as SVHC.

Once an SVHC is determined, it is included in the Candidate List. Suppliers of substances included in the list would be obliged to do some of the following:

a. Supplying a safety data sheet

b. Communicating on safe use

c. Responding to consumer requests

d. Notifying the ECHA if the article they produce contains an SVHC in quantities above one tonne per year and if those substances is present in the article above a concentration of 0.1% (w/w)

However, once a substance from the Candidate List is selected for the authorisation list, applications for authorisation to continue or start placing such substances on the market would need to be made.

Restriction of Chemicals

Restrictions on certain chemical substances or mixtures and articles containing certain chemicals are employed to ensure that it is safe to introduce to the public and the environment. Such restrictions may impose limits, bans, and conditions on manufacturers and importers. Said restrictions may even apply to such substances and articles that do not require registration.

Substance restrictions are set out in Annex XVII to REACH and are further explained in subsequent sections.

Articles

Articles under REACH means an object which in the course of production is given a unique shape, surface or design which determines the object’s functioning to a greater degree than does its chemical composition. Article suppliers have various obligations under REACH depending on whether:

a. The article contains a SVHC or restricted substance

b. The article contains a substance that is intended to be released

In subsequent sections, we cover the responsibilities of article manufacturers and importers.

Chemicals

Under the REACH regulations, a “substance” refers to a chemical element and its compounds in the natural state or acquired through any manufacturing process such as silver and nickel.

A “mixture” is a solution that consists of two or more substances such as paints and washing powder. Said substances and mixtures are controlled in the EU and are the subject of the REACH regulations.

Responsibilities

Suppliers of substances, mixtures, and articles have obligations and responsibilities under REACH regulations. The following are different types of suppliers and their respective responsibilities. Note that certain entities may fulfil multiple roles (for instance, an entity can be both an importer and a manufacturer).

Manufacturers

Manufacturers have some of the following responsibilities:

a. Substance identification to assess whether the substance is in the Authorisation List, the list of restrictions or has a harmonised classification and labelling requirements

b. Communication or notification obligations for substances, mixtures and substances in articles

c. Registration obligation for substances, mixtures and substances in articles

d. Sharing of information to prevent unnecessary animal testing and costs

Importers

Importers also share similar responsibilities to the manufacturer, including:

a. Substance identification to assess whether the substance is in the Authorisation List, the list of restrictions or has a harmonised classification and labelling requirements

b. Providing information to buyers (like the safety data sheets, labelling, and providing other information)

c. Communication or notification obligations for substances, mixtures and substances in articles

d. Registration obligation for substances, mixtures and substances in articles

Downstream users

Under the REACH regulations, a downstream user is a natural or legal person who uses substances or mixtures in the course of his industrial or professional activities. Thus, consumers would not be considered to be downstream users.

Downstream users have some of the following responsibilities:

a. Providing information for suppliers on new hazard information

b. Preparing a chemical safety report in accordance with Annex XII regarding the use of the substance or mixture

c. Identify, apply, and recommend appropriate measures to control risks identified

Companies established outside the EU

Companies outside of the EU are not compelled to follow the REACH regulations. This includes situations where outside companies are exporting products to the EU. The entities that bear the responsibility to comply with REACH would be importers and representatives of a non-EU manufacturer established in the EU.

Substances of Very High Concern (SVHC)

Importers and manufacturers must observe whether the substance, mixture or article-containing substances are identified as SVHCs. SVHCs are substances that have hazards with serious consequences (e.g. cancer-causing or other hazardous properties).

If the substance identified is included in the candidate list and is present in articles above concentration levels of 0.1 % w/w, the two obligations may occur:

a. Notification to ECHA of substances in articles

b. Communication of information relating to identified substances down the supply chain

Annex XVII

Annex XVII of the REACH regulations contains substances, groups of substances, and mixtures with their respective restriction conditions. As previously mentioned the restrictions may even apply to such substances and articles that do not require registration.

The following are some substances and groups of substances, and some of their respective restrictions:

a. DEHP, DBP, BBP, DIBP phthalates – Limited to quantities under 0.1% by weight in toys, childcare items and plasticised materials

b. Lead and its compounds – Limited to concentrations under 0.05% by weight in jewellery articles

c. Chromium VI compounds – Limited to concentrations equal to or below 0.0002% of the total dry weight of cement and cement-containing mixtures

d. Toluene – Limited to concentrations under 0.1 % by weight where its substance or mixture is employed in adhesives or spray paints and is intended for the general public

Note that other conditions may apply and that you should from time to time check on whether updates have occurred.

Annex XIV

Importers and manufacturers that wish to continue using a substance included in the Authorisation List (Annex XIV) after the sunset date, would need to submit an application for authorisation before the latest application date and acquire a positive authorisation from the European Commission.

The latest application date for a substance listed on the Authorisation List is on the first of November, 2023. Thus, for instance, if you wanted to continue to use the substance “Tetraethyllead” which is used in fuels after the sunset date (set on the first of May, 2025), then you would have until next year to lodge your application.

Other Annexes (Summary)

The REACH regulations include a number of Annexes that are relevant to importers and manufacturers. Below is a table summarizing said Annexes. Note that the table below is not an exhaustive one and that there may be other Annexes that may be relevant to your situation.

Annex	Description
Annex I	This contains general provisions for assessing substances and preparing chemical safety reports which are necessary for registration purposes
Annex II	This contains requirements for the compilation of safety data sheets
Annex VI	This contains information requirements necessary for registration purposes
Annexes VII to X	These Annexes set out the information requirements for all substances imported or manufactured in various quantities in accordance with article 12
Annex XV	This contains general principles for preparing dossiers

Labelling

In relation to labelling requirements, various parts of the REACH regulations have been amended by the classification, labelling and packaging regulation ((EC) No 1272/2008) (“CLP”). The CLP contains provisions on the classification and labelling of substances and mixtures, inclusive of certain articles.

The CLP aims to protect users by means of labelling which communicates the possible hazardous effects of dangerous substances.

Because multiple REACH provisions are related to substance classification, importers and manufacturers of substances and mixtures should consider both regulations when making plans for their product(s), and apply labels when necessary.

Other than substances and mixtures, importers and manufacturers of the following articles are affected by the CLP regulation:

a. Explosive articles as described in section 2.1 of Annex I of the CLP regulation

b. Articles requiring registration or notification of substance(s) contained therein pursuant to articles 7 or 9 of the REACH regulation

Testing Requirements

To ensure compliance with the REACH regulation, importers and manufacturers may have to have their products tested such as SVHC screening tests or tests relating to restricted substances contained in Annex XVII of the REACH regulation.

Additionally, as the CLP regulation is related to REACH registration and notification requirements, importers and manufacturers of substances, mixtures, and certain articles may have to test their products as per the testing requirements under the CLP regulation.

Consumer rights

Upon request by a consumer, importers and manufacturers of articles meeting the following criteria are required to provide sufficient information about the presence of SVHC (or substances that may be considered to be SVHC in the future):

a. The article contains a substance that meets the criteria in Article 57 of REACH

b. The article contains a substance that is identified in accordance with Article 59(1) of REACH in a concentration above 0.1% weight by weight

The information provided should be free of charge and supplied within 45 days of receiving the request.

FAQ

Are there any differences between the UK and the EU REACH regulations?

Post-Brexit, the UK separated from the EU and now has its own UK REACH regulation and related procedures. Despite this, the UK REACH remains a near replica of its EU counterpart.

However, importers and manufacturers interested in the UK market should remain vigilant as it is likely that the UK’s current REACH system will go through more legislative updates that may or might not differ from its EU counterpart.

Which REACH restrictions relate to textiles and leather articles?

The following substances are restricted under REACH for textile and leather articles (the Annex XVII list entries are provided for each restricted substance):

• Cadmium and its compounds – entry 23
• Azocolourants and azodyes – entry 43
• Tris(aziridinyl)phosphinoxide – entry 7
• Polybromobiphenyls; Polybrominated biphenyls (PBB) – entry 8

Which REACH restrictions relate to toys and childcare articles?

The following substances are restricted under REACH for toys and childcare articles (the Annex XVII list entries are provided for each restricted substance):

• DEHP, DBP, BBP, and DIBP – Entry 51
• DINP, DIDP, and DNOP – Entry 52

Which REACH restrictions relate to Electrical and Electronic Equipment?

Annex XVII entries may not explicitly refer to electrical and electronic equipment. However, even if they do not explicitly refer to such products, certain substance restrictions may apply.

Annex XVII contains derogations for certain substance restrictions relating to electrical and electronic equipment:

• Diphenylether, octabromo derivative – entry 45
• Lead and its compounds – entry 63