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User obligations

   
 

The obligations of a company under REACH depend on the exact activity carried out in relation to a specific substance, either on its own, in a preparation or in an article. Therefore a professional user of chemicals has first to identify his role(s) under REACH for each substance he uses in order to be in position to identify his obligations.


Identification of roles under REACH

REACH makes a distinction among the different actors in the supply chain between manufacturers, importers, downstream users and distributors (including retailers and storage providers).

A downstream user is defined in article 3(13) of REACH as “any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user.” Many different types of companies can be downstream users, including formulators of preparations, industrial users, craftsmen, workshops and service providers or re-fillers.
The first condition for a user to be regarded as downstream user according to REACH is to purchase substances and/or preparations from an EU supplier1 or from a non-EU supplier who has an “only representative”2. The user may also reimport substances (as such or in preparations) which have originally been produced in the EU and registered in the same supply chain. Further conditions take into account the different possible activities of users. They are given in the table below.

Trade

Activities

Further conditions to be considered
as downstream user under REACH

Formulator

The company mixes substances and/or preparations to make preparations placed on the market.

No chemical reaction occurs during mixing. Example:
dissolving a substance is not manufacturing a substance but a use. However, mixing an acid and a base which results in a new substance (salt) placed on the market is considered as manufacture and the company as manufacturer.

Article producer

The company incorporates substances and/or preparations into articles and they become an integral part of such articles (in the context of an industrial process or a professional activity).

If the substance is present in those articles in quantities totalling over one tonne per producer per year and is intended to be released under normal or reasonably foreseeable conditions of use, it must have already been registered for that use.

If the substance is identified for eventual inclusion in annex XIV of REACH (list of substances subject to authorisation) and,

  1. is present in those articles in quantities totalling over one tonne per producer per year and,
  2. is present in those articles above a concentration of 0.1% weight by weight and,
  3. the exposure to humans or the environment cannot be excluded during normal or reasonably foreseeable conditions of use including disposal,

the substance must have already been registered for that use.

End-user

The company uses substances and preparations in the context of an industrial process or a professional activity. It does not supply them further downstream.

Substance(s) resulting from a chemical reaction occurring upon use of other substances is/are exempted, in principle, from the registration requirement (REACH annex V).

Re-filler

This actor transfers substances or preparations from one container to another.
This transfer (re-packaging) is considered as use under REACH.

 

Whenever the above conditions are not fulfilled, an actor using chemicals is considered under REACH as manufacturer or importer of substances/preparations or producer/importer of articles, depending on his activities. He may be required to register or notify substances in addition to the obligations related to their use.

Under REACH, other actors in the supply chain are distributors. They only store and make substances, preparations and/or articles available to third parties without further processing. Their sole duty under REACH is to transmit information down and up the supply chain.


Obligations of downstream users

Under REACH, there are obligations that apply only to specific types of downstream users. This depends on the trade in the supply chain and the activity carried out. The following table identifies the possible obligations related to different activities.

Type of downstream users

Obligations

Formulators and re-fillers only

Substances they place on the market must be registered substances if registration is required (registration is the duty of manufacturers and importers).

They must provide up-to-date information to customers (downstream users or distributors) to enable safe use of substances or preparations: safety data sheets or other information when a safety data sheet is not required.

Article producers only

They must provide information to customers (downstream users or distributors) of articles containing substance(s) identified for eventual inclusion in annex XIV of REACH above 0.1% w/w and if requested, to consumers.
Note: as these substances of very high concern are not listed yet, article producers have to be watchful and follow any future development on this subject.

Re-importers only

They must document that substance(s) are the same as those registered by themselves or another actor of the same supply chain.

All downstream users

For substances subject to authorisation, they must comply with the conditions of the authorisation covering a specific use. The downstream user may need to apply for an authorisation if his use is not covered by an authorisation granted to his supplier.

They must check compliance with any restrictions on the substance.

They have to identify and apply appropriate measures to control the risks communicated in the safety data sheet or via other information when a safety data sheet is not required.

They must check compliance with an exposure scenario when the safety data sheet received includes this element and take further action in case of non-compliance.

They must inform suppliers of any new information on substance hazards, including classification and labelling.

They have to communicate information to suppliers that might call into question the appropriateness of the risk management measures given in the safety data sheet for identified uses.

Moreover, most of the current legal requirements that apply to the use of chemicals, for instance those related to the protection of workers, consumers and the environment, will continue to apply alongside REACH.

1. EU suppliers are established in one of the 27 member states. Suppliers in Switzerland are not EU suppliers. Suppliers in Norway, Iceland and Liechtenstein will be considered as EU suppliers once these countries have implemented REACH.
2. An only representative is a natural or legal person established in EU who is appointed by a non-EU manufacturer of a substance, a preparation or an article, to fulfil the registration obligations on importers.

Prévention du risque chimique, France, 2007
This document is provided for information only and under no circumstances constitutes legal advice. The only authentic legal reference is the text of the REACH Regulation (Regulation (EC) n° 1907/2006).