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Substances which can be used and put on the market


Among the obligations a downstream user may face under REACH, he has first to check whether he is allowed or not to use and put on the market a given substance.

Substances subject to registration

Under REACH, downstream users must not use and place on the market any substances which are not registered if registration is required. This means that the products used and put on the market may contain only substances which:

  • are manufactured/imported by the manufacturer or the importer in amounts below 1 tonne per year, or
  • are exempted from REACH or specifically from registration, or which
  • have been (or are going to be) pre-registered1 and have a later registration deadline, or
  • registered2

This applies to substances on their own, those in preparations and those which are intended to be released from articles3 under normal or reasonably foreseeable conditions of use. In practise, the downstream user should make sure that his supplier is aware of REACH and complies with his requirements. If the supplier is a distributor or another downstream user, he has to pass this request to the next actor up the supply chain. If a large number of substances are concerned, it may not be feasible to contact all suppliers at once, the downstream user may therefore wish to focus his resources first on the most important substances. But this means that the use of the other substances may be at risk due to a possible non-compliance with REACH.

Substances subject to notification

Substances used for the purposes of product and process orientated research and development (PPORD) may receive exemption from registration if they are notified to the European Chemicals Agency. This exemption applies for 5 years and may be extended for up to a further 5 years (10 years in the case of medicinal products or substances not put on the market) upon request, as long as this can be justified by the programme of research and development. The exemption applies only to the quantity of substance being used for the purposes of PPORD by the manufacturer or importer himself or in cooperation with a limited number of listed customers. The Agency could decide to impose conditions to ensure that the substance will be handled only by staff of listed customers in reasonably controlled conditions and that remaining quantities will be re-collected for disposal after the exemption period. A downstream user of a substance, who is listed as one of the selected customers with whom the manufacturer or importer cooperates in a PPORD notification has to use the substance for the purpose of PPORD and within any conditions set by the Agency and communicated to him by his supplier.

Another type of notification concerns some substances of very high concern present in articles. If a substance is identified for eventual inclusion in annexe XIV of REACH (list of substances subject to authorisation) and is present in quantities totalling over one tonne per year in all articles manufactured by the producer, in a concentration of above 0.1% weight by weight – if not already registered for that use – the substance must be notified (except if exposure to humans or the environment can be excluded during normal or reasonably foreseeable conditions of use including disposal). To avoid any break in the supply chain due to the lack of notification (or registration), the downstream user should make sure that the producer of articles up his supply chain complies with REACH.

Substances subject to authorisation

The use of some substances may be subject to an authorisation requirement. This will be indicated by the supplier, either in the section 15 of the safety data sheet or as part of information given when a safety data sheet is not required. Downstream users may also check the following lists published by the Agency: the list of candidate substances for eventual inclusion in annexe XIV of REACH (substances subject to authorisation), the recommendations for substances to be included in annexe XIV (first recommendations by 1 June 2009) and annexe XIV itself when available.
A downstream user may use a substance subject to an authorisation, provided that his use is in accordance with the conditions of a granted authorisation4 to an actor up his supply chain. He must report to the Agency at the latest 3 months after first receiving an authorised substance as such or in preparation. If his use is not covered by such an authorisation, and he wants to continue it, the downstream user will have to apply himself for an authorisation for his own use and if relevant, for his customers’ use.
If no application for authorisation is made, the downstream user must stop using the substance by the sunset date5 specified in annexe XIV and the substance as such or in a preparation must not be supplied to his customers after this date.

A substance listed in annexe XIV may be used for uses which are exempted from authorisation. A downstream user has thus to check whether his use is exempted or not. If it is exempted, he can continue his use without an authorisation. Nevertheless, he has to implement the conditions of use and risk management measures communicated by his supplier.

Substances subject to restrictions

Under REACH, restrictions may limit the use of a substance. If restrictions apply to a substance, either on its own or in a preparation or article, the downstream user may only continue to use it if he complies with these restrictions. The supplier must include information on whether a substance he supplies is subject to restrictions in section 15 of the safety data sheet. If a safety data sheet is not required, the supplier is required to provide information on any substances subject to restrictions.
In some cases, the restriction may take the form of an outright ban on the use of the substance, in which case the downstream user will no longer be able to use it (the date of prohibition is specified in annexe XVII of REACH). In other cases, specific uses may be prohibited or other conditions applied, to control the risks of the substance. As for authorisations, the downstream user has to check whether his use is exempted from a restriction or not.

1. REACH creates a special transition regime for substances which, under certain conditions, were already being manufactured or placed on the market before the entry into force of the regulation on 1 June 2007. These substances called “phase-in substances” are being subjected to the registration system in different phases over time, rather than immediately in one go. A precondition to benefit from the transition regime is the pre-registration of phase-in substances. Pre-registration takes place in the six-month period from 1 June 2008 to 1 December 2008. By 1 January 2009, the Agency publishes the list of the pre-registered substances on its website. If a substance is not on the list, a downstream user can express his interest in it to the Agency. The Agency will then publish on its website the name of the substance. On request from a potential registrant, the Agency will provide him with the downstream user’s contact details. First time manufacturers and importers of phase-in substances exceeding 1 tonne per year after 1 December 2008 can still submit a pre-registration to the Agency. This on the condition that the pre-registration takes place within 6 months of first manufacture/import and providing the date of pre-registration is at least 12 months before the relevant registration deadline.
2. Once the registration is complete for a given substance, a registration number is assigned to the registrant for the substance concerned. It will have to be incorporated in the safety data sheet for any supply after reception of that number.
3. Article producers must pre-register/register a substance present in their articles in quantities totalling over one tonne per year and intended to be released under normal or reasonably foreseeable conditions of use, if the substance concerned has not been already registered for that use (up the same supply chain or in any other supply chain).
It should also be noted that the Agency may require under certain conditions, registration for substances present in articles but which are not intended to be released.
4. The number of the granted authorisation is given on the chemical label.
5. Sunset date: date from which the placing on the market and the use of the substance shall be prohibited unless an authorisation is granted.

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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).