Трябва ли моето вещество да бъде регистрирано?

Once you know the identity of your substance, you need to see if your substance needs to be registered or if it is exempt from registration.

On ECHA’s website you can check if your substance is already registered. That is a first indication of whether your substance needs to be registered.

 

Step 1. Check if your substance as such is exempt from registration

The following substances do not need to be registered, regardless of how you use them:

  • Polymers: substances meeting the definition of a polymer under REACH do not need to be registered, but the monomers and other substances used for the manufacture of the polymer may need to be registered.
  • Substances covered by Annex V to REACH: this list describes 13 broad categories of substances.
  • Substances included in Annex IV to REACH: this list contains 68 low-risk substances, typically of natural origin, including water.
  • Radioactive substances: substances giving off such radiation that humans and the environment need to be protected are regulated by the Euratom Directive.
  • Substances covered by a national exemption in the interest of defence.
Step 2. Check if the use of your substance is exempt from registration
Substances do not need to be registered when only used
 
  • as non-isolated intermediates: intermediates that during the synthesis are not intentionally removed from the equipment in which the synthesis takes place (except for sampling).
  • for product and process orientated research and development (PPORD): exempt from registration for five years (extensions possible), if you notify your PPORD activities to ECHA.
  • in food or feeding stuffs (including uses as additives or flavourings).
  • in medicinal products for human or veterinary use as active substances or excipients.
  • in biocidal products or plant protection products as active substances. These are regarded as already registered.

If your substance is also used for other purposes not exempt, it will need to be registered for those uses.

 

Step 3. Check if your substance is exempt from registration because of its origin or history
The following substances do not need to be registered:
 
  • substances already registered, exported and re-imported to the EEA. 
  • substances under customs supervision, with a view to re-exportation. 
  • waste: substances which are discarded as waste (from households, professionals or industry) as defined in the Waste Framework Directive do not need to be registered, but substances produced from the recovery of waste generally need to be registered; except
  • recovered substances already registered.
The following substances have some specific provisions under REACH but are not exempt from registration: 
 
  • Nano particles 
  • Non-hazardous substances and not-classified substances 
  • Substances in cosmetic products
  • Food contact materials
  • Fuels 
  • Substances present in mixtures below certain concentration limits
  • On-site or transported isolated intermediates 
  • Substances of very high concern 
  • Substances subject to authorisation or restriction 
  • Substances notified under Directive 67/548/EEC by someone else 
If you previously notified, your notification is now regarded as a registration under REACH and you have the obligation to keep this registration up-to-date. 

 

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