REACH obligations of manufacturers and importers

REACH knowledge base – REACH obligations of manufacturers and importers

 

Tasks to be carried out when importing substances or mixtures

 

1. Pre-registration / Registration

Steps for determining the registration obligation:

  • Determine the quantity of the imported substance.
  • Check the exemptions.
  • Does the supplier have an Only Representative / a REACH registration?

 

2. Classification

For manufactured or imported substances, hazard classification is the responsibility of the manufacturer or importer. Classification is mandatory irrespective of the quantity.

After examining the relevant conditions, the classification of the substance may be determined in the following ways:

Harmonised classification
If the substance is listed in Annex VI to Regulation (EC) No 1272/2008, the classification given there is mandatory.
If a different classification is used, a report (with appropriate justification) must be submitted to the Agency.

Own classification
For substances not listed in Annex VI to Regulation (EC) No 1272/2008, classification may be based on own tests or on the supplier’s recommendation.

 

3. Taking restrictions into account

Check the substances listed in Annex XVII to REACH.

Substances listed in the above Annex may be restricted for certain uses, which also means that they may be used without restriction for non-restricted uses.

 

4. Authorisation (prohibition on placing substances subject to authorisation on the market)

For more information, see our article on the authorisation of SVHC substances.

 

5. Notification to the Classification and Labelling Inventory

The manufacturer or importer may be obliged to notify a substance when all of the following criteria are met:

  • The substance is already on the market and is subject to registration (≥ 1 tonne/year).
  • The substance is already on the market and is classified as hazardous under CLP, irrespective of the quantity.

Deadline:
within 1 month

Exemption:
If the substance has already been notified to the Classification and Labelling Inventory during registration.

 

6. Providing information to buyers (SDS or other relevant information)

 

If your company is located outside the EU/EEA but places hazardous mixtures on the EU market, in most cases you will also need to address PCN obligations and EU legal representation for non-EU companies, in addition to the REACH duties described here.

Tasks to be carried out when importing articles

 

1. Registration

Registration of substances in articles is required when all conditions listed in Article 7 of the REACH Regulation are fulfilled:

  • In the articles concerned, the substance is present in a quantity exceeding one tonne per year.*
  • The substance is intended to be released under normal or reasonably foreseeable conditions of use (i.e. an intended release** occurs during use).

* When calculating the quantity, it is necessary to consider not only the quantity of the substance to be released, but also its total quantity in the article.

** Intended release does not occur during the primary function of the product.

Examples for interpreting the statement above:

  • The release of ink from an ink cartridge used in a printer is not included, as it is the primary function of the article.
  • The release of fragrance from a perfumed paper tissue is included.
  • The release of nicotine from a nicotine patch is not included.

However, an exemption may apply if another actor has already registered that substance (you can check pre-registered or registered substances on the Agency’s website).

If there is a registration obligation for a substance, a chemical safety assessment must also be carried out (above 10 tonnes/year).

 

2. Tasks related to substances of very high concern (SVHCs)

  • Authorisation
  • Communication

 

3. Taking restrictions into account

Based on Annex XVII to REACH.

 

Recommended article(s) 

 

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