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Last updated on 04 Jan, 2022

REACH

 

Overview of REACH 

REACH is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.

In principle, REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances. Therefore, the regulation has an impact on most companies across the EU.

 

How does REACH work?

REACH establishes procedures for collecting and assessing information on the properties and hazards of substances. Companies need to register their substances and to do this they need to work together with other companies who are registering the same substance.

ECHA receives and evaluates individual registrations for their compliance, and the EU Member States evaluate selected substances to clarify initial concerns for human health or for the environment. Authorities and ECHA's scientific committees assess whether the risks of substances can be managed.

Authorities can ban hazardous substances if their risks are unmanageable. They can also decide to restrict a use or make it subject to a prior authorisation.

 

REACH’s effect on companies

REACH impacts on a wide range of companies across many sectors, even those who may not think of themselves as being involved with chemicals.

In general, under REACH you may have one of these roles:

Manufacturer: If you make chemicals, either to use yourself or to supply to other people (even if it is for export), then you will probably have some important responsibilities under REACH.

Importer: If you buy anything from outside the EU/EEA, you are likely to have some responsibilities under REACH. It may be individual chemicals, mixtures for onwards sale or finished products, like clothes, furniture or plastic goods.

Downstream users: Most companies use chemicals, sometimes even without realising it, therefore you need to check your obligations if you handle any chemicals in your industrial or professional activity. You might have some responsibilities under REACH.

Companies established outside the EU: If you are a company established outside the EU, you are not bound by the obligations of REACH, even if you export their products into the customs territory of the European Union. The responsibility for fulfilling the requirements of REACH, such as registration lies with the importers established in the European Union, or with the only representative of a non-EU manufacturer established in the European Union.

REACH products are regulated in the EU by the REACH Regulation (Regulation (EU) 1907/2006).

 

Legislation

 

What's happening with tattoo inks in the EU –

Restriction of hazardous substances in tattoo inks and permanent make-up

To protect European citizens, thousands of hazardous chemicals found in tattoo inks and permanent make-up are restricted in the EU under the REACH Regulation from January 2022. The aim is not to ban tattooing but to make the colours used in tattoos and permanent make-up safer.

Please find more information on this restriction here.

Furthermore, the restriction and Annex for further guidance on the restricted substances can be found here. 

 

Placing on the market

The anti-poison centre in Malta is being offered by the Medicines and Poisons Information Service at Mater Dei Hospital (MDH). However, the appointed body responsible for receiving information related to emergency health response is currently MCCAA.

There is currently a transitional period whereby notification can either be done with MCCAA. However, please note that eventually notification will also have to been done with ECHA through the following link: https://poisoncentres.echa.europa.eu/poison-centres-notification-format.  

Notification with the MCCAA can be done by sending the safety data sheets (SDSs) and the information below to [email protected]:  

  1. the name or names or trademarks of the product;
  2. the name and address, telephone and fax numbers and, if available, the e-mail address, of the responsible person that makes the product available on the Maltese market;
  3. the country of origin in the case of import from outside the European Community;
  4. the qualitative and quantitative composition of the product;
  5. the physical-chemical properties of the product;
  6. any field of application and use;
  7. the labelling of the product, as applicable, (according to Regulation (EC) No 1272/2008);
  8. a copy of the original label of the final product

 

Further Information

 

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