REACH

A. Introduction

The key elements of the REACH-Regulation (Regulation (EC) 1907/2006) are the registration, evaluation, authorisation and restriction of chemical substances. The Regulation is directly applicable in the Member States of the European Union since it entered into force on 1 June 2007.

Aim

REACH has the aim “to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation” (Article 1(1)).

Principle

The REACH Regulation is founded on the principle that manufacturers, importers, and downstream users are responsible for ensuring that the substances they produce, market, or use do not pose a risk to human health or the environment. This regulatory framework is guided by the precautionary principle.

Accordingly, the “no data, no market” rule applies, meaning that a substance can only be manufactured or placed on the market if the necessary data for its registration have been generated. Substances of Very High Concern (SVHCs) are to be gradually replaced with suitable alternatives or technologies, provided these are economically and technically feasible. Substances fulfilling the conditions listed under Article 57 of the REACH regulation can be defined as SVHC in accordance with the procedure laid down in Article 58. SVHCs are listed in ECHA’s Candidate List on ECHA CHEM.

The implementation of the technical, scientific and administrative aspects of REACH is undertaken by the European Chemicals Agency (ECHA) in Helsinki.

Processes under REACH

• Registration of all substances above one tonne per annum by the manufacturer or importer.
• Evaluation of selected registration dossiers and substances by ECHA and Member States.
• Identification and authorisation of Substances of Very High Concern.
• Restriction of the manufacture, use or placing on the market of certain hazardous substances, mixtures or articles.

Areas of application

REACH covers the manufacture, marketing and use of chemical substances whether they are used on their own (e.g., methanol or sodium hydroxide), in mixtures (e.g., paints), or incorporated into articles (e.g., textiles, tires, etc.).

Exceptions of the application are listed in Article 2 of the regulation.

Role under REACH

Under REACH you can have specific obligations for each individual substance you manufacture, import or use. Your obligations depend on your role in the supply chain (manufacturer, importer, distributor, user of chemicals…) for the specific substance.Even for mixtures or articles, most of the REACH obligations relate to the substances that are contained in them.

If your substance or mixture is classified as hazardous, you will also need to comply with CLP provisions.

Visit ECHA’s website to assess your role and obligations in the supply chain and to access all information related to guidance.

In this section, we will focus on the safety data sheet (SDS) and Article 33 of REACH that were mentioned in the simplified supply chain chart for EU legislation. Detailed guidance documents on the registration, evaluation, authorisation and restriction of chemical substances can be found on ECHA's website.

B. Some definitions

Article 3 of the REACH regulation provides definitions for terms that are essential to the regulation. Here we present the REACH definitions for ‘substance’, ‘mixture’ and ‘article’.

• ‘Substance: means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.’
• ‘Mixture: means a mixture or solution composed of two or more substances.’
• ‘Article: means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.’  This definition applies to almost all solid products such as textiles, furniture, shoes, sports equipment, toys or electronic devices and to each individual component of an assembled article, if this component comes under the REACH article definition.

C. Safety Data Sheet (SDS)

Safety Data Sheets (SDS) play a critical role in sharing information throughout the supply chain, including end users such as professional workers. They ensure that manufacturers and importers provide the necessary details to promote the safe use of substances and mixtures at every stage of their life cycle.

In addition to SDS, product labels serve as a key source of hazard information accessible to users, including both workers and consumers. Together, these tools help ensure that chemical risks are clearly communicated and understood.

A SDS includes comprehensive information such as the substance's properties, associated hazards, safe handling instructions, disposal methods and transport guidelines. It also outlines appropriate conditions for use and risk management measures to ensure both human health and the environment.

Regulatory provisions

A SDS is mandatory (Article 31(1)) when:

• a substance or mixture fulfils the classification criteria as a dangerous product according to the CLP Regulation, or;
• a substance is persistent, bio-accumulative and toxic, or very persistent and very bio-accumulative, according to the criteria in Annex XIII REACH, or;
• a substance is included in the list of substances that are candidates for Authorisation (SVHC) which could possibly be subjected to Authorisation in the future according to Article 59(1) REACH.

A SDS is not required:

• in the case of articles,
• for hazardous substances and mixtures made available to the general public (Article 31(4)), if the information for a safe use of the substances or a mixture is sufficient.

A SDS must be supplied on request (Article 31(3)) for certain mixtures that are not classified but contain at least one substance:

• that presents a danger for health or the environment, in an individual concentration of ≥ 1 % by weight for non-gaseous mixtures and ≥ 0.2 % by volume for gaseous mixtures;
• being PBT (persistent, bioaccumulative and toxic), vPvB (very persistent, bioaccumulative and toxic), or SVHC in an individual concentration ≥ 0.1 % by weight for non-gaseous mixtures;
• having an EU workplace exposure limit.

SDS are to be provided free of charge on paper, or in electronic format (Article 31(8)) and in the official language of the Member State in which the substance is being placed on the market (Article 31(5)). Information on the required languages of the SDS for each Member State is accessible in a document made available on ECHA’s website.

Update obligations

SDS must be updated (Article 31(9)): 

• as soon as new information which can affect the management of risks or new information regarding hazards are made available;
• once an authorisation (under REACH) is granted or denied;
• as soon as a restriction (under REACH) has been adopted.

In addition, it is recommended to regularly review and update a SDS.

The updated SDS is disseminated free of charge to all the former recipients for whom the providers have supplied the substance or mixture within the last 12 months.

SDS content

The content of a SDS is defined in Annex II REACH and is divided into 16 sections.

The Guidance on the compilation of safety data sheets, which is available on ECHA’s Website, supplies the practical details on data that must be included in each section of a SDS.

D. Requirements for Candidate List substances in articles

To ensure a high level of protection from the use of substances with serious effects on human health or the environment, their presence in articles and any relevant information on safe use need to be laid open and communicated in the supply chain, as this is a prerequisite for the identification and application of appropriate risk management measures. It also empowers both operators and consumers to make informed purchasing decisions. Detailed information can be found in ECHA’s Guidance on requirements for substances in articles.

Candidate list substances

Substances meeting one or more criteria defined in Article 57 of REACH can be identified as Substances of Very High Concern (SVHC) and placed on the Candidate List for authorisation. These substances include:

• CMR substances (carcinogenic, mutagenic or reprotoxic, category 1A or 1B),
• PBT or vPvB substances (persistent, bioaccumulative and toxic / very persistent and very bioaccumulative),
• Substances with equivalent levels of concern (e.g. endocrine disruptors).

The Candidate List is regularly updated by ECHA. Companies are advised to monitor ECHA's Public Activities Coordination Tool (PACT) to anticipate future listings and prepare for compliance obligations in advance.

Communication of Candidate List Substances in Articles (Article 33)

According to Article 33, any supplier of an article must provide relevant safety information to the recipient of the article or, upon request, to a consumer when the following two conditions are met:

• The substance is included in the Candidate List for authorisation, and
• The substance is present in the article at a concentration above 0.1% weight by weight (w/w).

Regarding the obligations to communicate information on substances in articles (both to recipients and consumers), please note the following:

• Information must be provided to professional users and distributors the first time an article is supplied after a substance has been added to the Candidate List. For consumers, this information must be provided upon request, within 45 calendar days of the request and free of charge.
• At minimum, the name of the substance must always be communicated, even if no additional safety information is deemed necessary.
• The 0.1% w/w threshold applies to each individual article, including articles that form part of a complex object (a product made up of more than one article).
• There is no tonnage threshold that triggers these communication obligations.
• A distributor cannot simply refer consumers to their own supplier – they must provide the information themselves.
• Obligations apply regardless of whether the supplier is aware of the substance's presence; it is therefore in the supplier's interest to proactively seek such information.

Suppliers must communicate information sufficient to allow the safe use of articles containing Candidate List substances (>0.1% w/w). This means considering all foreseeable life-cycle stages including processing, (re)packaging, end use, recycling, and disposal.

Information on safe use should cover:

• Use conditions (e.g. temperature, frequency, duration, indoor/outdoor)
• Risk management measures to reduce exposure and emission

The appropriate level of detail varies depending on the recipient (industrial user vs. consumer). For complex objects, communication obligations apply to each constituent article containing a Candidate List substance above the threshold. REACH does not prescribe a specific format; possible formats include modified instructions for use, labels, standard industry communication formats, or IT systems.

Notification of Candidate List substances in articles (Article 7(2))

Notification of a substance in articles is required from producers and importers of articles when all the following conditions of Article 7(2) are met:

• The substance is included in the Candidate List for authorisation.
• The substance is present in articles produced and/or imported above a concentration of 0.1% (w/w).
• The total amount of the substance present in all articles produced and/or imported, which contain more than 0.1% (w/w) of the substance, exceeds 1 tonne per actor per year.
• Exemptions do not apply.

Notifications must be submitted no later than 6 months after the substance is added to the Candidate List, and must include:

• Identity and contact details of the producer/importer,
• Registration number of the substance (if available),
• Identity and classification of the SVHC (available from the Candidate List),
• A brief description of the substance's use in the article(s) and the article's use,
• The tonnage range of the substance in articles (1–10 t, 10–100 t, 100–1,000 t, or ≥1,000 t).

More detailed information is given on how to provide this information within the notification in the Manual - How to prepare a substance in articles notification. Notifiers are strongly encouraged - though not legally required - to keep their notifications up to date if the notified information changes (e.g. tonnage range or new articles).