REACH
REGULATION

What is REACH?

Regulation (EC) No 1907/2006, better known as REACH, is the acronym for Regulation on the registration, evaluation, authorisation and restriction of chemical substances.

This regulation, mandatory throughout the European Union was adopted in order to improve the protection of human health and the environment against the risks derived from chemical products, while maintaining the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard evaluation of substances in order to reduce the number of tests on animals.

In principle, REACH applies to all chemicals, not just those used in industrial processes, but also those used by consumers, for example cleaning products, paints and items such as clothing, furniture and electrical appliances. This is why the Regulation affects most companies in the EU.

REACH Regulation procedures

To meet these goals, the REACH Regulation covers the following processes:

• Registration (Title II): all substances manufactured/imported in quantities equal to or greater than 1 ton/year must be registered.
• Evaluation (Title VI): the risks to health and the environment of all hazardous substances will be evaluated in accordance with the criteria established for assigning priorities.
• Authorisation (Title VII): an authorisation for use must be requested for all substances considered of high concern according to the REACH Regulation.
• Restriction (Title VIII): certain uses of substances will be prohibited or restricted when they pose an unacceptable risk to human health and the environment.

How are hazards communicated under REACH?

Regulation (CE) No 1907/2006 (REACH) legislates on safety data sheets (SDS) which, together with labelling, regulated by by Regulation (CE) No 1272/2008 (CLP) form the elements of hazard communication throughout the supply chain.

Article 31 of REACH establishes the requirements as to when and how it is necessary to provide a safety data sheet (SDS), prepared in accordance with Regulation (EU) 2020/878.

According to which criteria is it necessary to prepare a safety data sheet?

Regulation (EU) 2020/878 amending Annex II of Regulation (EC) No 1907/2006 (REACH) establishes the requirements for the preparation of safety data sheets in terms of format, content and other information requirements.

The safety data sheet will include the following sixteen sections in accordance with Article 31, Paragraph 6, as well as the subsections indicated below:

• SECTION 1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING
  • 1.1. Product identifier
  • 1.2. Relevant identified uses of the substance or mixture and uses advised against
  • 1.3. Details of the supplier of the safety data sheet
  • 1.4. Emergency telephone number
• SECTION 2. HAZARDS IDENTIFICATION
  • 2.1. Classification of the substance or mixture
  • 2.2. Label elements
  • 2.3. Other hazards
• SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
  • 3.1. Substances
  • 3.2. Mixtures
• SECTION 4. FIRST AID MEASURES
  • 4.1. Description of first aid measures
  • 4.2. Most important symptoms and effects, both acute and delayed
  • 4.3. Indication of any immediate medical attention and special treatment needed
• SECTION 5. FIREFIGHTING MEASURES
  • 5.1. Extinguishing media
  • 5.2. Special hazards arising from the substance or mixture
  • 5.3. Advice for firefighters
• SECTION 6. ACCIDENTAL RELEASE MEASURES
  • 6.1. Personal precautions, protective equipment and emergency procedures
  • 6.2. Environmental precautions
  • 6.3. Methods and material for containment and cleaning up
  • 6.4. Reference to other sections
• SECTION 7. HANDLING AND STORAGE
  • 7.1. Precautions for safe handling
  • 7.2. Conditions for safe storage, including any incompatibilities
  • 7.3. Specific end use(s)
• SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
  • 8.1. Control parameters
  • 8.2. Exposure controls
• SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
  • 9.1. Information on basic physical and chemical properties
  • 9.2. Other information
• SECTION 10. STABILITY AND REACTIVITY
  • 10.1. Reactivity
  • 10.2. Chemical stability
  • 10.3. Possibility of hazardous reactions
  • 10.4. Conditions to avoid
  • 10.5. Incompatible materials
  • 10.6. Hazardous decomposition products
• SECTION 11. TOXICOLOGICAL INFORMATION
  • 11.1. Information on the hazard classes as defined in Regulation (EC) No 1272/2008
  • 11.2. Information on other hazards
• SECTION 12. ECOLOGICAL INFORMATION
  • 12.1. Toxicity
  • 12.2. Persistence and degradability
  • 12.3. Bioaccumulation potential
  • 12.4. Mobility in soil
  • 12.5. Results of PBT and vPvB assessment
  • 12.6. Endocrine disrupting properties
  12.7. Other adverse effects
• SECTION 13. DISPOSAL CONSIDERATIONS
  • 13.1. Waste treatment methods
• SECTION 14. TRANSPORT INFORMATION
  • 14.1. UN number or ID number
  • 14.2. UN proper shipping name
  • 14.3. Transport hazard class(es)
  • 14.4. Packing group
  • 14.5. Environmental hazards
  • 14.6. Special precautions for user
  • 14.7. Maritime transport in bulk according to IMO instruments
• SECTION 15. REGULATORY INFORMATION
  • 15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
  • 15.2. Chemical safety assessment
• SECTION 16. OTHER INFORMATION

Are safety data sheets (SDS) the same in all countries of the European Union?

Although Regulation (EU) 2020/878 establishes the requirements for the preparation of safety data sheets the content must be adapted to the national regulations of each country, as well as being written in the official language(s) of each country.

Regulation (EU) 2020/878 requires the inclusion of information on national laws which apply European regulations, such as:

• For coatings (paints and varnishes), if applicable, reference to Directive 2004/42/EC on the limitation of emissions of volatile organic compounds
• For detergents, the declaration of ingredients according to Regulation 648/2004/EC on detergents.
• Etc.

Likewise, Regulation (EU) 2020/878 requires the inclusion of any other relevant national legislation, such as:

• In Spain:
  • Storage of chemicals
  • Technical-sanitary regulation on the production, circulation and sale of detergents and cleaners (Royal Decree 770/1999)
  • Technical-sanitary regulation on the production, circulation and sale of bleaches
• In Germany:
  • Wassergefährdungsklassenii (WGK)
  • TA-Luft
  • Technische Regeln für Gefahrstoffe, for example, TRGS 220
• In France:
  • Tableaux de maladies professionnelles
  • Nomenclature des installations classées pour la protection de l‘environnementIn
• In netherlands:
  • Lijst van kankerverwekkende, mutagene, en voor de voortplanting giftige stoffen SZW
  • De Algemenebeoordelingsmethodiek Water (ABM).
  • De Nederlandse Emissierichtlijn (NeR)In Denmark:Lister over stoffer og processer, der anses for at være kræftfremkaldende.
• In Denmark:
  • Mal-koder (Mal-Code).

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