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REACH Q & A (Nov. 2006)

Disclaimer:  The answers to these questions are based on the current understanding of the REACH regulatory text and are therefore for guidance only. The text will be subject to legal interpretation and it is possible that legal challenges may arise. The application of REACH will be amplified by official guidance. All this is still under development. Decisions should not be taken based on these answers. Detailed technical and legal advice should be sought in individual cases.

1. Can you confirm the deadline for notification of substances in articles? Their slide deck indicates that notification begins 42 months after entry into force for REACH, but the deadline appears to extend out to 11 years after EIF (entry into force).  Is this right?

The list of substances of very high concern (SVHC) is due to be published by the Agency 3 years after entry into force of REACH. The notification of SVHC (substances of very high concern) in articles (various conditions apply) then starts 6 months after this and continues as long as the requirement is in the Regulation. There is no 11 year deadline.  If the REACH text, as currently drafted (N.B. not finalised yet), stays as it is then the notification of SVHC in articles would continue as long as REACH is in existence or until this provision is changed.

2. What is the current thinking regarding protection of confidential business information (CBI) for manufacturers of substances?  It seems that producers of articles can inform the Chemical Agency if they do not want to communicate a proprietary use of a substance through their supply chain (for example, the supplier is also a competitor)?

A downstream user may do their own Chemical Safety Assessment (CSA), conditions apply, and notify the Agency if they do not want to make their use an ‘identified use’ and pass information on it up the supply chain e.g. to a supplier who is also a competitor. Also see the answer to Q3 below.

3. What information will be available to industry through the proposed REACH-IT system? Will companies have visibility to what substances have been registered and for what uses? What is the timeframe for the system to be in place and populated? How does this timeframe match against the deadlines for notification of substances in articles?

Confidential Business Information and REACH-IT: see Articles 117 and 118. In short,

Published on web, free of charge:

Information on substance identity,

classification,

physicochemical data,

results of toxicological and ecotoxicological studies,

DNELs, PNECs,

guidance on safe use,

analytical methods.

Published on web, free of charge, unless companies justify otherwise:

Information on tonnage bands,

impurities,

information in the SDS (unless above)

study summaries/robust study summaries.

Normally not published to protect commercial interests:

Composition of a preparation

Precise use, function or application

Precise tonnage

Links down supply chain

The REACH-IT system is due to be in place when REACH enters into force (EIF). Registrations will not start until 12 months after EIF and both the Agency and the REACH-IT systems should be fully operational by then. The first Registration deadline is before the start of notification for SVHC in articles so if the system is not working fully by then there will be serious problems.

4. As I understand it, an exporter of articles into the EU that contains chemicals, has no registration responsibility under REACH. Am I correct?

The duties can only apply to EU entities (e.g. companies based in the EU). It is therefore the EU based importer who has duties placed on them. In practical terms the US exporter will probably need to help and support the EU importer in meeting their duties under REACH (e.g. collection and generation of information, preparation of Registration dossiers).

5. A company has service agreements with chemical commodity management companies which supply the majority of their chemicals for use in manufacturing, maintenance use, or article inclusion. These management companies either produce the chemical or import it. In these scenarios, my company would be a downstream and article user and have only the requirement to insure the chemicals we are provided are registered by the commodity management company. Am I correct?

Cannot give an answer based on this information; are they EU based? Is ‘your’ company an EU entity? If ‘your’ company is EU based then the duties for registration would fall on the EU manufacturer and/or EU based importer. If you are their customer, and EU-based, then yes you would be a Downstream User.

6. If my facilities purchased chemicals from outside the EU directly from a company in the US, would we be the importer and subject to the importer requirement of REACH?

If you are EU based, yes assuming the chemicals enter into the EU.

7. Does REACH apply for importation of chemical from 1 EU state to another?

Assuming that this refers to Registration, no. The company in a 2nd EU Member State would be a Downstream User (DU). The ‘first’ company would potentially have to register the substance if they are the manufacturer or importer and based in the EU.

8. If a US-based company exports 500 tonnes of substance x into Europe (assume that the substance is listed on European Inventory of Existing Chemical Substances (i.e. is an ‘existing’ substance) and is not otherwise exempt). What are their duties under REACH?

The US-based company has no duties under REACH. The duties will be placed on the EU-based importer. Note: EU-based importers may decide to only import the substance if they are given appropriate support from the (US) exporter such as information required for registration. The importer may be responsible for the imports they deal with only (e.g. into one EU Member State) or may be appointed by a US-based manufacturer as the ‘only representative’ covering the import of that substance into all EU Member States. An ‘only representative’ has to satisfy all the REACH duties that apply to that substance from the US-based manufacturer.

The importer will have to provide a safety data sheet (SDS) on first supply to all its customers. Note: the SDS will have to be updated as and when new information comes to light (e.g. as a result of registration) and when exposure scenarios are produced for ‘identified’ uses. Most EU-based importers will depend on the non-EU manufacturer for such information and keeping it updated. The importer will have to pre-register the substance between 12 and 18 months after REACH comes into force. Again they are likely to be dependent to a large extent on the US-based manufacturer for help with this. The importer will have to cooperate with other potential registrants (e.g. EU manufacturers and EU-based importers) of the same substance to produce a common hazard data-set for registration; ‘one substance one registration’ (OSOR). Much of this work will be highly technical and may also have confidentiality implications; the non-EU manufacturer is likely to need and/or want to support the importer in this activity.

The importer will need to make a registration within 6 years of REACH entering into force (for a volume of 500 metric tonnes per year). Note: the importer will need hazard and exposure data which it may get from the US-based exporter. The registration should cover uses identified by EU-based downstream users; i.e. the chemical safety assessment needs to address the uses for which the substance is supplied. Again this is a highly technical and scientific exercise which is likely to require the support of the non-EU manufacturer.

The importer will have to supply classification and labelling information on the substance within three years for the Classification and Labelling Inventory. The importer will have to comply with any restrictions imposed on the substance and its uses. If the substance is a ‘substance of very high concern’ (SVHC) the importer will have to apply for an authorisation of each use as and when the substance is listed in Annex XIV (List of Substances Subject to Authorisation). Note: only a limited number of substances will be brought forward for authorisation every year.

This is a non-exhaustive list. Each case should be considered separately and detailed and legal advice sought. However, it is clear that if a non-EU manufacturer is to maintain an interest in the EU market they will need to provide considerable support to the EU-based importer.

9. A US company producing a substance that is exported to the EU for the treatment of fabric used in the manufacture of chairs are concerned that the substance may be affected by the authorisation process.

Only Substances of Very High Concern (SVHC) are affected by the authorisation process. Is the substance included on the list of SVHC published on the new European Chemicals Agency website? If yes it is potentially subject to authorisation. Is the substance listed on Annex XIV (list of substances subject to authorization)? If yes, an authorisation application is needed for the use in question by the deadline given. If a substance is listed on Annex XIV and the deadline for applications has passed only authorised uses are allowed and even then only as long as you are in the same supply chain as the company granted the authorisation. If the deadline has passed a new application may be made but the use is not allowed in this case until the use has been authorised. The EU-based importer (or ‘only representative’) of the substance would be responsible for submitting any authorisation required. Note: they are likely to require considerable support from the US-based exporter otherwise they may stop importation or go to another supplier who can give them the support they need. The authorisation application would need to include the use of the substance in fabric treatment in order for it to continue to be used.

If you suspect that the substance is a Substance of Very High Concern but has not been included on the Agency list you should check the list regularly to see if it has been added. Note: the importer has a duty to provide information on the properties of the substance and to use this information to classify the substance.

10. A US company export a red paint to Europe. What are their duties?

REACH applies equally whether a substance on its own or in a preparation is imported into the EU. The duties are therefore as Q8. The registration deadline per substance will depend on the amount of each substance in the preparation. Note: the EU-based importer will have to add together the amounts of each substance in all the preparations they import. If a substance is not on European Inventory of Existing Chemical Substances (i.e. it is a ‘new’ substance) it will have to be registered as a ‘non-phase in’ substance i.e. registered immediately and before starting supply. If this is the case the EU-based importer will require immediate support from the US company to meet the registration requirements immediately.