REACH obligations of manufacturers and importers
REACH knowledge base – REACH obligations of manufacturers and importers
Tasks to do in case of importing substances or mixtures
1. Pre-registration / Registration
Steps of determining the registration obligation:
- Determination of the quantity of the imported substance
- Checking the exemptions
- Does the supplier have an only representative /a REACH registration?
2. Classification
For manufactured or imported substances, the hazard classification is the responsibility of the manufacturer or importer. Classification is mandatory irrespective of the quantity!
After examining the appropriate conditions, the classification of the substance can take place in the following ways:
Harmonised classification
If the substance is listed in Annex VI of Regulation (EC) No 1272/2008. the classification given therein is mandatory.
In case of using a different classification, a report (with appropriate justification) shall be submitted to the Agency.
Own classification
In case of substances not listed in Annex VI of Regulation (EC) No 1272/2008 classification can be made based on own tests or on the recommendation of the supplier.
3. Taking into account the restrictions
Checking the substances in Annex XVII of REACH.
Materials in the above Annex might be limited to certain uses, which also means that the substance may be used without limitation for non-designated uses.
4. Authorization (ban on placing substances subject to authorization on the market)
For more information, check out our article about the authorization of SVHC substances.
5. Notification to the classification and labelling inventory
The manufacturer or importer might have obligation to notify the substance, when all the following criteria are met:
- Substance – already on the market – to be registered (≥ 1 tonne / year)
- Substance – already on the market – classified as hazardous by CLP, irrespective of the quantity.
Deadlines:
within 1 month
Exemption:
If the substance has already been notified to the Classification and Labeling Inventory during the registration.
6. Providing information to buyers (SDS or other relevant information)
- Safety data sheet creation/update
- Labelling
- Providing other information – REACH communication
Tasks in case of importing articles
1. Registration
Registration of substances in articles is required when all conditions listed under Article 7 of the REACH Regulation are fulfilled:
- In the given articles the substance is present in a quantity that exceeds one tonne per year*
- The substance is intended to be released under normal or reasonably foreseeable conditions of use (intended release** happens during its intended use)
* In calculating the quantity, it is necessary to calculate not only the quantity of the substance to be released, but also its total quantity in the article.
** The intended release does not occur during the primary function of the product.
Examples for the interpretation of the statement above:
- The ink release of the ink cartridge used in a printer is not included, as it is the primary function of the article
- the fragrance release of a perfumed paper tissue is included
- nicotine release of the nicotine patch is not included
However, we may be exempted if someone has registered that substance (you can check the pre-registered or actually registered substances on the website of the Agency).
If there is a registration obligation for a substance, a chemical safety assessment must be also made (over 10 tonnes / year).
2. Tasks related to substances of very high concern (SVHC)
- Authorization
- Communication
3. Taking into account the restrictions
Based on Annex XVII to REACH.
Recommended article(s)