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PREAMBLE: REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals [go to this PREAMBLE]
... (17) All available and relevant information on substances on their own, in preparations and in articles should be collected to assist in identifying hazardous properties, and recommendations
about risk management measures should systematically be conveyed through supply chains, as reasonably necessary, to prevent adverse effects on human health and the environment. In addition, communication
of technical advice to support risk management should be encouraged in the supply chain, where appropriate. ...
... (17) All available and relevant information on substances on their own, in preparations and in articles should be collected to assist in identifying hazardous properties, and recommendations
about risk management measures should systematically be conveyed through supply chains, as reasonably necessary, to prevent adverse effects on human health and the environment. In addition, communication
of technical advice to support risk management should be encouraged in the supply chain, where appropriate. ...
... (25) The responsibility to assess the risks and hazards of substances should be given, in the first place, to the natural or legal persons that manufacture or import substances, but only when they do so in quantities exceeding a certain volume, to enable them to carry the associated burden. Natural
or legal persons handling chemicals should take the necessary risk management measures in accordance with the assessment of the risks of substances and pass on relevant recommendations along the supply chain. This should include describing, documenting and notifying in an appropriate and transparent fashion the risks stemming
from the production, use and disposal of each substance. ...
... (54) In order to avoid duplication of work, and in particular to avoid duplication of testing, registrants of phase-in substances should pre-register as early as possible with a database managed by the Agency. A system should be established in order to provide for the establishment of Substance Information Exchange Forums (SIEF) to help exchange of information on the substances that have been registered. SIEF participants should include all relevant actors submitting information to the Agency on the same phase-in substance. They should include both potential registrants, who must provide and be supplied with any
information relevant to the registration of their substances, and other participants, who may receive financial compensation for studies they hold but are not entitled to request information. In order to ensure the smooth functioning of that system they should
fulfil certain obligations. If a member of a SIEF does not fulfil his obligations, he should be penalised accordingly but
other members should be enabled to continue preparing their own registration. In cases where a substance has not been pre-registered, measures should be taken to help downstream users find alternative sources of supply. ...
... (55) Manufacturers and importers of a substance on its own or in a preparation should be encouraged to communicate with the downstream users of the substance with regard to whether they intend to register the substance. Such information should be provided to a downstream user sufficiently in advance of the relevant registration deadline if the manufacturer or importer does not intend to register the substance, in order to enable the downstream user to look for alternative sources of supply. ...
... (56) Part of the responsibility of manufacturers or importers for the management of the risks of substances is the communication of information on these substances to other professionals such as downstream users or distributors. In addition, producers or importers of articles should supply information on the safe use of articles to industrial and professional users, and consumers on request. This important responsibility
should also apply throughout the supply chain to enable all actors to meet their responsibility in relation to management of risks arising from the use of substances. ...
... (56) Part of the responsibility of manufacturers or importers for the management of the risks of substances is the communication of information on these substances to other professionals such as downstream users or distributors. In addition, producers or importers of articles should supply information on the safe use of articles to industrial and professional users, and consumers on request. This important responsibility
should also apply throughout the supply chain to enable all actors to meet their responsibility in relation to management of risks arising from the use of substances. ...
... (57) As the existing safety data sheet is already being used as a communication tool within the supply chain of substances and preparations, it is appropriate to develop it further and make it an integral part of the system established by this
Regulation. ...
... (58) In order to have a chain of responsibilities, downstream users should be responsible for assessing the risks arising from their uses of substances if those uses are not covered by a safety data sheet received from their suppliers, unless the downstream user concerned takes more protective measures than those recommended by his supplier or unless his supplier was not required to assess those risks or provide him with information on those risks. For the same reason, downstream users should manage the risks arising from their uses of substances. In addition, it is appropriate that any producer or importer of an article containing a substance of very high concern should provide sufficient information to allow safe use of such
an article. ...
... (58) In order to have a chain of responsibilities, downstream users should be responsible for assessing the risks arising from their uses of substances if those uses are not covered by a safety data sheet received from their suppliers, unless the downstream user concerned takes more protective measures than those recommended by his supplier or unless his supplier was not required to assess those risks or provide him with information on those risks. For the same reason, downstream users should manage the risks arising from their uses of substances. In addition, it is appropriate that any producer or importer of an article containing a substance of very high concern should provide sufficient information to allow safe use of such
an article. ...
... (58) In order to have a chain of responsibilities, downstream users should be responsible for assessing the risks arising from their uses of substances if those uses are not covered by a safety data sheet received from their suppliers, unless the downstream user concerned takes more protective measures than those recommended by his supplier or unless his supplier was not required to assess those risks or provide him with information on those risks. For the same reason, downstream users should manage the risks arising from their uses of substances. In addition, it is appropriate that any producer or importer of an article containing a substance of very high concern should provide sufficient information to allow safe use of such
an article. ...
... (62) Communication up and down the supply chain should be facilitated. The Commission should develop a system categorising brief general descriptions of uses taking
into account the outcomes of the RIPs. ...
... (70) Adverse effects on human health and the environment from substances of very high concern should be prevented through the application of appropriate risk management measures to ensure that any
risks from the uses of a substance are adequately controlled, and with a view to progressively substituting these substances with a suitable safer substance. Risk management measures should be applied to ensure, when substances are manufactured, placed on the market and used, that exposure to these substances including discharges, emissions and losses, throughout the whole life-cycle is below the threshold level beyond which adverse
effects may occur. For any substance for which authorisation has been granted, and for any other substance for which it is not possible to establish a safe level of exposure, measures
should always be taken to minimise, as far as technically and practically possible, exposure and emissions with a view to
minimising the likelihood of adverse effects. Measures to ensure adequate control should be identified in any Chemical Safety
Report. These measures should be applied and, where appropriate, recommended to other actors down the supply chain. ...
... (82) To allow effective monitoring and enforcement of the authorisation requirement, downstream users benefiting from an authorisation granted to their supplier should inform the Agency of their use of the substance. ...
ARTICLE-2: Application [go to this ARTICLE]
... (c) substances on their own or in preparations, registered in accordance with Title II, exported from the Community by an actor in the supply chain and re-imported into the Community by the same or another actor in the same supply chain who shows that: ...
... (c) substances on their own or in preparations, registered in accordance with Title II, exported from the Community by an actor in the supply chain and re-imported into the Community by the same or another actor in the same supply chain who shows that: ...
ARTICLE-3: Definitions [go to this ARTICLE]
... 17. actors in the supply chain: means all manufacturers and/or importers and/or downstream users in a supply chain; ...
... 17. actors in the supply chain: means all manufacturers and/or importers and/or downstream users in a supply chain; ...
... 26. identified use: means a use of a substance on its own or in a preparation, or a use of a preparation, that is intended
by an actor in the supply chain, including his own use, or that is made known to him in writing by an immediate downstream user; ...
... 32. supplier of a substance or a preparation: means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a preparation, or a preparation; ...
... 33. supplier of an article: means any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market; ...
... 33. supplier of an article: means any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market; ...
ARTICLE-6: General obligation to register substances on their own or in preparations [go to this ARTICLE]
... 3. Any manufacturer or importer of a polymer shall submit a registration to the Agency for the monomer substance(s) or any other substance(s), that have not already been registered by an actor up the supply chain, if both the following conditions are met: ...
ARTICLE-7: Registration and notification of substances in articles [go to this ARTICLE]
... 3. Paragraph 2 shall not apply where the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use including disposal.
In such cases, the producer or importer shall supply appropriate instructions to the recipient of the article. ...
ARTICLE-8: Only representative of a non-Community manufacturer [go to this ARTICLE]
... 2. The representative shall also comply with all other obligations of importers under this Regulation. To this end, he shall have a sufficient background in the practical handling of substances and the information related to them and, without prejudice to Article 36, shall keep available and up-to-date information on quantities imported and customers sold to, as well as information on
the supply of the latest update of the safety data sheet referred to in Article 31. ...
... 3. If a representative is appointed in accordance with paragraphs 1 and 2, the non-Community manufacturer shall inform
the importer(s) within the same supply chain of the appointment. These importers shall be regarded as downstream users for the purposes of this Regulation. ...
ARTICLE-28: Duty to pre-register for phase-in substances [go to this ARTICLE]
... 5. After the publication of the list a downstream user of a substance not appearing on the list may notify the Agency of his interest in the substance, his contact details and the details of his current supplier. The Agency shall publish on its website the name of the substance and on request provide contact details of the downstream user to a
potential registrant. ...
ARTICLE-31: Requirements for safety data sheets [go to this ARTICLE]
... 1. The supplier of a substance or a preparation shall provide the recipient of the substance or preparation with a safety data sheet compiled in accordance with Annex II: ...
... 2. Any actor in the supply chain who is required, under Articles 14 or 37, to carry out a chemical safety assessment for a substance shall ensure that the information in the safety data sheet is consistent with the information in this assessment. If the safety data sheet is developed for a preparation and the actor in the supply chain has prepared a chemical safety assessment for that preparation, it is sufficient if the information in the safety data sheet is consistent with the chemical safety report for the preparation instead of with the chemical safety report for each substance
in the preparation. ...
... 2. Any actor in the supply chain who is required, under Articles 14 or 37, to carry out a chemical safety assessment for a substance shall ensure that the information in the safety data sheet is consistent with the information in this assessment. If the safety data sheet is developed for a preparation and the actor in the supply chain has prepared a chemical safety assessment for that preparation, it is sufficient if the information in the safety data sheet is consistent with the chemical safety report for the preparation instead of with the chemical safety report for each substance
in the preparation. ...
... 3. The supplier shall provide the recipient at his request with a safety data sheet compiled in accordance with Annex II, where a preparation does not meet the criteria for classification as dangerous in accordance with Articles 5, 6 and 7 of
Directive 1999/45/EC, but contains: ...
... 7. Any actor in the supply chain who is required to prepare a chemical safety report according to Articles 14 or 37 shall place the relevant exposure scenarios (including use and exposure categories where appropriate) in an annex to the
safety data sheet covering identified uses and including specific conditions resulting from the application of Section 3 of Annex XI. ...
... 9. Suppliers shall update the safety data sheet without delay on the following occasions: ...
ARTICLE-32: Duty
to communicate information down the supply chain for substances on
their own or in preparations for which a safety data sheet is not
required [go to this ARTICLE]
... Duty
to communicate information down the supply chain for substances on
their own or in preparations for which a safety data sheet is not
required ...
... 1. Any supplier of a substance on its own or in a preparation who does not have to supply a safety data sheet in accordance with Article 31 shall provide the recipient with the following information: ...
... 1. Any supplier of a substance on its own or in a preparation who does not have to supply a safety data sheet in accordance with Article 31 shall provide the recipient with the following information: ...
... (b) if the substance is subject to authorisation and details of any authorisation granted or denied under Title VII in this supply chain; ...
... 3. Suppliers shall update this information without delay on the following occasions: ...
ARTICLE-33: Duty to communicate information on substances in articles [go to this ARTICLE]
... 1. Any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the recipient of the article with sufficient information, available to the
supplier, to allow safe use of the article including, as a minimum, the name of that substance. ...
... 1. Any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the recipient of the article with sufficient information, available to the
supplier, to allow safe use of the article including, as a minimum, the name of that substance. ...
... 2. On request by a consumer any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the consumer with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance. ...
... 2. On request by a consumer any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the consumer with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance. ...
ARTICLE-34: Duty to communicate information on substances and preparations up the supply chain [go to this ARTICLE]
... Duty to communicate information on substances and preparations up the supply chain ...
... Any actor in the supply chain of a substance or a preparation shall communicate the following information to the next actor or distributor up the
supply chain: ...
... Any actor in the supply chain of a substance or a preparation shall communicate the following information to the next actor or distributor up the
supply chain: ...
... Distributors shall pass on that information to the next actor or distributor up the supply chain. ...
ARTICLE-37: Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures [go to this ARTICLE]
... Distributors shall pass on such information to the next actor or distributor up the supply chain. Downstream users in receipt of such information may prepare an exposure scenario for the identified use(s), or pass the information to the next actor up the supply chain. ...
... Distributors shall pass on such information to the next actor or distributor up the supply chain. Downstream users in receipt of such information may prepare an exposure scenario for the identified use(s), or pass the information to the next actor up the supply chain. ...
... 3. For registered substances, the manufacturer, importer or downstream user shall comply with the obligations laid down in Article 14 either before he next supplies the substance on its own or in a preparation to the downstream user making the request referred
to in paragraph 2 of this Article, provided that the request was made at least one month before the supply, or within one month after the request, whichever is the later. ...
... Where the manufacturer, importer or downstream user, having assessed the use in accordance with Article 14, is unable to include it as an identified use for reasons of protection of human health or the environment, he shall provide
the Agency and the downstream user with the reason(s) for that decision in writing without delay and shall not supply downstream user(s) with the substance without including these reason(s) in the information referred to under Articles 31 or 32. The manufacturer or importer shall include this use in Section 3.7 of Annex VI in his update of the registration in accordance with Article 22(1)(d). ...
... 4. A downstream user of a substance on its own or in a preparation shall prepare a chemical safety report in accordance
with Annex XII for any use outside the conditions described in an exposure scenario or if appropriate a use and exposure category communicated to him in a safety data sheet or for any use his supplier advises against. ...
... (b) a chemical safety report is not required to be completed by his supplier in accordance with Article 14; ...
ARTICLE-38: Obligation for downstream users to report information [go to this ARTICLE]
... 1. Before commencing or continuing with a particular use of a substance that has been registered by an actor up the supply chain in accordance with Articles 6 or 18, the downstream user shall report to the Agency the information specified in paragraph 2 of this Article, in the following cases: ...
... (d) the identity of the manufacturer(s) or the importer(s) or other supplier as specified in Section 1.1 of Annex VI; ...
... 4. A downstream user shall report to the Agency if his classification of a substance is different to that of his supplier. ...
ARTICLE-39: Application of downstream user obligations [go to this ARTICLE]
... 1. Downstream users shall be required to comply with the requirements of Article 37 at the latest 12 months after receiving a registration number communicated to them by their suppliers in a safety data sheet. ...
... 2. Downstream users shall be required to comply with the requirements of Article 38 at the latest six months after receiving a registration number communicated to them by their suppliers in a safety data sheet. ...
ARTICLE-56: General provisions [go to this ARTICLE]
... 2. A downstream user may use a substance meeting the criteria set out in paragraph 1 provided that the use is in accordance
with the conditions of an authorisation granted to an actor up his supply chain for that use. ...
ARTICLE-66: Downstream users [go to this ARTICLE]
... 1. Downstream users using a substance in accordance with Article 56(2) shall notify the Agency within three months of the first supply of the substance. ...
ARTICLE-138: Review [go to this ARTICLE]
... (b) the distribution of costs between actors in the supply chain and the downstream user; ...
ARTICLE-I: GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS [go to this ARTICLE]
... 0.1. The purpose of this Annex is to set out how manufacturers and importers are to assess and document that the risks arising from the substance they manufacture or import are adequately controlled during manufacture and their own use(s) and that others further down the supply chain can adequately control the risks. This Annex shall also apply adapted as necessary to producers and importers of articles required to make a chemical safety assessment as part of a registration. ...
ARTICLE-II: GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS [go to this ARTICLE]
... This Annex sets out the requirements for a Safety Data Sheet that is provided for a substance or a preparation in accordance with Article 31. The Safety Data Sheet provides a mechanism for transmitting appropriate safety information on classified substances and preparations, including information from the relevant Chemical Safety Report(s) down the supply chain to the immediate downstream user(s). The information provided in the Safety Data Sheet shall be consistent with the information in the Chemical Safety Report, where one is required. Where a Chemical Safety Report
has been performed, the relevant exposure scenario(s) shall be placed into an annex of the Safety Data Sheet, to make reference to them under the relevant headings of the Safety Data Sheet easier. ...
... In addition to the above mentioned information, supply the emergency telephone number of the company and/or relevant official advisory body (this may be the body responsible for
receiving information relating to health, which is referred to in Article 17 of Directive 1999/45/EC). Specify if this phone
number is available only during office hours. ...
... Indicate any other information which the supplier assesses as being of importance for the health and safety of the user and for the protection of the environment, for example:
...
... - recommended restrictions on use (i.e. non-statutory recommendations by supplier), ...
ARTICLE-VI: INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10 [go to this ARTICLE]
... Where applicable, an indication of the uses which the registrant advises against and why (i.e. non-statutory recommendations
by supplier). This need not be an exhaustive list. ...
ARTICLE-XI: GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X [go to this ARTICLE]
... 3.2. In all cases, adequate justification and documentation shall be provided. The justification shall be based on an
exposure assessment in accordance with Section 5 of Annex I and be consistent with the criteria adopted pursuant to Section 3.3, and the specific conditions of use must be communicated
through the chemical supply chain in accordance with Articles 31 or 32. ...
ARTICLE-XII: GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS [go to this ARTICLE]
... The purpose of this Annex is to set out how downstream users are to assess and document that the risks arising from the substance(s) they use are adequately controlled during their use
for a use not covered by the Safety Data Sheet supplied to them and that other users further down the supply chain can adequately control the risks. The assessment shall cover the life-cycle of the substance, from its receipt by the
downstream user, for his own uses and for his identified uses further down the supply chain. The assessment shall consider the use of the substance on its own, in a preparation or in an article. ...
... The purpose of this Annex is to set out how downstream users are to assess and document that the risks arising from the substance(s) they use are adequately controlled during their use
for a use not covered by the Safety Data Sheet supplied to them and that other users further down the supply chain can adequately control the risks. The assessment shall cover the life-cycle of the substance, from its receipt by the
downstream user, for his own uses and for his identified uses further down the supply chain. The assessment shall consider the use of the substance on its own, in a preparation or in an article. ...
... In carrying out the chemical safety assessment and producing the Chemical Safety Report, the downstream user shall take
account of information received from the supplier of the chemical in accordance with Article 31 and 32 of this Regulation. Where available and appropriate, an assessment carried out under Community legislation, (e.g. risk assessments completed under Regulation (EEC) No 793/93) shall be taken into account in the chemical safety assessment and be reflected
in the Chemical Safety Report. Deviations from such assessments shall be justified. Assessments carried out under other international and national programmes may also be taken into account. ...
... STEP 2: IF NECESSARY, A REFINEMENT OF THE HAZARD ASSESSMENT BY THE SUPPLIER ...
... If the downstream user considers the hazard and PBT assessments reported in the Safety Data Sheet supplied to him to be appropriate, then no further hazard assessment or PBT and vPvB assessment is necessary. In this case he shall use the relevant information reported by the supplier for the risk characterisation. This shall be stated in the Chemical Safety Report. ...
... In those cases where the downstream user considers that information in addition to that provided by the supplier is necessary for producing his Chemical Safety Report the downstream user shall gather this information. Where this information
can only be obtained by testing on vertebrate animals, he shall submit a proposal for a testing strategy to the Agency in accordance with Article 38. He shall explain why he considers that additional information is necessary. While waiting for results of further testing,
he shall record in his chemical safety report the risk management measures intended to manage the risks being explored that
he has put in place. ...
... Part A of the Chemical Safety Report shall include a declaration that the risk management measures outlined in the relevant
exposure scenarios are implemented by the downstream user for his own uses and that the risk management measures outlined
in the exposure scenarios for the identified uses are communicated down the supply chain. ...
ARTICLE-XVI: SOCIO-ECONOMIC ANALYSIS [go to this ARTICLE]
... - impact of a granted or refused authorisation on the applicant(s), or, in the case of a proposed restriction, the impact on industry (e.g. manufacturers and importers). The impact on all other actors in the supply chain, downstream users and associated businesses in terms of commercial consequences such as impact on investment, research and development, innovation, one-off and operating costs (e.g. compliance, transitional arrangements, changes to existing processes, reporting
and monitoring systems, installation of new technology, etc.) taking into account general trends in the market and technology,
...