reach regulation compliance

I. About REACH

REACH (EC) No. 1907/2006 came into force on June 1st, 2007. REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. This EU Regulation aims to ensure a high level of protection of human health and the environment. It also promotes the use of alternative methods for hazard assessment of chemical substances and the free circulation of such substances on the EU internal market while improving competitiveness and innovation.

REACH lays down requirements on substances and preparations (i.e., a mixture composed of two or more substances) used in manufacturing products. The Regulation’s provisions also apply to the manufacture, placing on the market and use of substances on their own or in preparations. Thus, REACH has an impact on most businesses across the EU.

II. Scope of REACH

REACH applies to chemicals used in industrial processes and almost all types of products sold on the EU market – for example, detergents, furniture, medical devices, clothes, toys and electrical products. There are only a few exceptions when REACH doesn’t apply. Namely:

  • radioactive substances covered by Directive 96/29/Euratom
  • non-isolated intermediates
  • substances which are subject to customs supervision, if they don’t undergo any treatment or processing, and which are in either temporary storage, a free zone/warehouse with a view to re-exportation or in transit
  • the transport of harmful substances on their own or in preparations by rail, road, inland waterway, sea or air

Additionally, the provisions of the Regulation don’t apply to some products if certain conditions are met. For more information, please refer to article 2 of Title I.

III. Restricted substances, preparations and articles

The REACH Regulation restricts the manufacture, placing on the market or use of the following hazardous substances, preparations and articles:

  • Preparations with a PCT content higher than 0,005 % by weight.
  • Chloro-1-ethylene
  • Liquid substances or preparations, which are regarded as dangerous per the definitions in Directive 67/548/EEC and Directive 1999/45/EC.
  • Tris phosphate
  • Benzene
  • Asbestos fibers
  • Tris phosphinoxide
  • Polybromobiphenyls and Polybrominated biphenyls (PBB)
  • Soap bark powder and its derivatives containing saponins
  • Benzidine and its derivatives
  • o-Nitrobenzaldehyde
  • Ammonium
  • Volatile esters of bromoacetic acids
  • 2-Naphthylamine
  • Benzidine
  • 4-Nitrobiphenyl
  • 4-Aminobiphenyl xenylamine
  • Lead carbons or sulphates
  • Mercury, arsenic or organostannic compounds
  • Pentachlorophenol and its salts and esters
  • Cadmium and its compounds
  • Ugilec 141, 121 and 21
  • DBBT and DBB
  • Nickel and its compounds
  • Substances in Annex I to Directive 67/548/EEC (only specific categories)
  • Creosote and creosote oil
  • Distillates (coal tar)
  • Anthracene oil
  • Tar acids, coal and crude
  • Chloroform
  • Carbon tetrachloride tetrachloromethane
  • Trichloroethane
  • Tetrachloroethane
  • Pentachloro ethane
  • Dichloroethylene
  • Substances meeting the criteria of flammability in Directive 67/548/EEC
  • Hexachloroethane
  • Alkanes
  • Azo colourants
  • Diphenyl ether
  • Nonylphenol
  • Cement
  • Toluene
  • Trichlorobenzene
  • Polycyclic-aromatic hydrocarbons
  • Phthalates (DEHP, DBP, BBP, DINP, DIDP and DNOP)

Detailed information on the conditions of restriction of each of the abovementioned substances, preparations or articles can be found in Annex XVII to the REACH Regulation.

IV. Does REACH affect you?

As mentioned above, REACH affects most companies across the EU, even those who may not think of themselves as being involved with chemicals. Generally speaking, REACH affects you if you have one of the following roles:

  • Manufacturer: If you produce chemicals, you need to check REACH as it may apply to you. If it does, your responsibilities don’t go away even if you export the chemicals you produce.
  • Importer: As an importer of products produced outside the EU/EEA, you need to make sure that the product’s chemical composition complies with the provisions of the REACH Regulation. 
  • Downstream users: A downstream user is any natural or legal person established within the EU who uses substances in their industrial or professional activities. Thus, if you associate yourself with this role, check your responsibilities under REACH. Also, keep in mind that a downstream user cannot be a distributor or a consumer.

Learn about the SCIP database, because if you need to comply with REACH, you also need to comply with SCIP.

In addition, it should be noted that if your company is established outside the EU’s borders, REACH doesn’t apply to you. This stays valid even if you export products into the EU because the responsibility for fulfilling the Regulation’s requirements lies with the EU-based importer or the EU authorised representative.

V. What information is required to register substances in articles?

According to article 10, you need to prepare and submit the following documentation when registering any substances present in your products:

  • A technical dossier
  • A chemical safety report if required under Article 14.

The technical dossier must include the following information:

  • the identity of the manufacturer or importer
  • the identity of the substance
  • information on the manufacture and use(s) of the substance
  • the classification and labelling of the substance under section 4 of Annex VI
  • advice on the safe use of the substance as stipulated in Section 5 of Annex VI
  • study summaries of the data obtained from the application of Annexes VII to XI
  • if applicable, robust study summaries of the data obtained from the application of Annexes VII to XI
  • an indication as to which of the above information has been reviewed by an assessor
  • for substances in quantities of 1 to 10 tons, exposure information as indicated in section 6 of Annex VI
  • proposals for testing
  • a request as to which of the information in Article 119(2) you consider shouldn’t be made available on the Internet in line with Article 77(2)(e).

VI. How to register chemical substances in articles?

According to article 5 of REACH, no substances on their own, in preparations or articles cannot be manufactured in the EU or placed on the EU market unless they have been registered with ECHA. The registration process includes several steps:

  • Check your REACH registration obligations and make sure you comply with each one of them, including preparing the required registration documentation (e.g. technical dossier)
  • Find if you have co-registrants by submitting an inquiry via REACH-IT
  • Come to an agreement on sharing data with your co-registrants. This means that if your substance is already registered, you must contact the lead registrant to become a member of the joint submission. If your substance is not registered, you need to agree with the other inquirers on how to organise your joint submission.
  • Check Annexes VI – X of REACH regarding what information you need for the joint part of your registration dossier. More on that here.
  • Create and submit your registration dossier
  • Receive a registration number showing that you have successfully completed the registration process
  • Keep your registration dossier updated.

For more information, please check the REACH registration page on the website of ECHA.

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