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downstream users
PREAMBLE: REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals [go to this PREAMBLE]
... (16) This Regulation lays down specific duties and obligations on manufacturers, importers and downstream users of substances on their own, in preparations and in articles. This Regulation is based on the principle that industry should manufacture,
import or use substances or place them on the market with such responsibility and care as may be required to ensure that, under reasonably foreseeable
conditions, human health and the environment are not adversely affected. ...
... (24) In preparation for this Regulation, the Commission has launched REACH Implementation Projects (RIPs), involving
relevant experts from stakeholder groups. Some of those projects aim at developing draft guidelines and tools which should
help the Commission, the Agency, Member States, manufacturers, importers and downstream users of substances to fulfil, in concrete terms, their obligations under this Regulation. This work should enable the Commission and the Agency to make available appropriate technical guidance, in due time, with regard to the deadlines introduced by this Regulation.
...
... (28) Scientific research and development normally takes place in quantities below one tonne per year. There is no need to exempt such research and development because substances in those quantities do not have to be registered in any case. However, in order to encourage innovation, product and process oriented research and development should be exempted from the obligation to register for a certain time period where a substance is not yet intended to be placed on the market to an indefinite number of customers
because its application in preparations or articles still requires further research and development performed by the potential registrant himself or in cooperation with a limited number of known customers. In addition, it
is appropriate to provide for a similar exemption to downstream users using the substance for the purposes of product and process oriented research and development, provided that the risks to human health and the environment are adequately controlled in accordance with the requirements
of legislation for the protection of workers and the environment. ...
... (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. ...
... (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. ...
... (59) The requirements for undertaking chemical safety assessments by downstream users should also be prescribed in detail to allow them to meet their obligations. These requirements should only apply above a
total quantity of one tonne of substance or preparation. In any case, however, the downstream users should consider the use and identify and apply appropriate risk management measures. Downstream users should report certain basic information on use to the Agency. ...
... (59) The requirements for undertaking chemical safety assessments by downstream users should also be prescribed in detail to allow them to meet their obligations. These requirements should only apply above a
total quantity of one tonne of substance or preparation. In any case, however, the downstream users should consider the use and identify and apply appropriate risk management measures. Downstream users should report certain basic information on use to the Agency. ...
... (59) The requirements for undertaking chemical safety assessments by downstream users should also be prescribed in detail to allow them to meet their obligations. These requirements should only apply above a
total quantity of one tonne of substance or preparation. In any case, however, the downstream users should consider the use and identify and apply appropriate risk management measures. Downstream users should report certain basic information on use to the Agency. ...
... (60) For enforcement and evaluation purposes, downstream users of substances should be required to report to the Agency certain basic information if their use is outside the conditions of the exposure scenario detailed in the safety data sheet communicated by their original manufacturer or importer and to keep such reported information up-to-date. ...
... (61) For reasons of workability and proportionality, it is appropriate to exempt downstream users using low quantities of a substance from such reporting. ...
... (66) The Agency should also be empowered to require further information from manufacturers, importers or downstream users on substances suspected of posing a risk to human health or the environment, including by reason of their presence on the internal market
in high volumes, on the basis of evaluations performed. Based on the criteria for prioritising substances developed by the Agency in cooperation with the Member States a Community rolling action plan for substance evaluation should be established, relying on Member State competent authorities to evaluate substances included therein. If a risk equivalent to the level of concern arising from the use of substances subject to authorisation arises from the use of isolated intermediates on site, the competent authorities of the Member States should also be allowed to require further information, when justified. ...
... (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-1: Aim and scope [go to this ARTICLE]
... 3. This Regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. Its provisions are underpinned by the precautionary principle.
...
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; ...
... 37. exposure scenario: means the set of conditions, including operational conditions and risk management measures, that describe how the substance
is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment. These exposure scenarios may cover one specific process or use or several
processes or uses as appropriate; ...
ARTICLE-4: General provision [go to this ARTICLE]
... Any manufacturer, importer, or where relevant downstream user, may, whilst retaining full responsibility for complying with his obligations under this
Regulation, appoint a third party representative for all proceedings under Article 11, Article 19, Title III and Article 53 involving discussions with other manufacturers, importers, or where relevant downstream users. In these cases, the identity of a manufacturer or importer or downstream user who has appointed a representative shall not normally be disclosed by the Agency to other manufacturers, importers, or, where relevant, downstream users. ...
... Any manufacturer, importer, or where relevant downstream user, may, whilst retaining full responsibility for complying with his obligations under this
Regulation, appoint a third party representative for all proceedings under Article 11, Article 19, Title III and Article 53 involving discussions with other manufacturers, importers, or where relevant downstream users. In these cases, the identity of a manufacturer or importer or downstream user who has appointed a representative shall not normally be disclosed by the Agency to other manufacturers, importers, or, where relevant, downstream users. ...
ARTICLE-8: Only representative of a non-Community manufacturer [go to this ARTICLE]
... 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]
... 7. Manufacturers or importers of phase-in substances in quantities of less than one tonne per year that appear on the list published by the Agency in accordance with paragraph 4 of this Article, as well as downstream users of those substances and third parties holding information on those substances, may submit the information referred to in paragraph 1 of this Article or any other relevant information to the Agency for those substances, with the intention of being part of the substance information exchange forum as referred to in Article 29. ...
ARTICLE-29: Substance Information Exchange Forums [go to this ARTICLE]
... 1. All potential registrants, downstream users and third parties who have submitted information to the Agency in accordance with Article 28, or whose information is held by the Agency in accordance with Article 15, for the same phase-in substance, or registrants who have submitted a registration for that phase-in substance before the deadline set out in Article 23(3), shall be participants in a substance information exchange forum (SIEF). ...
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. ...
... 7. Downstream users shall keep their chemical safety report up to date and available. ...
ARTICLE-38: Obligation for downstream users to report information [go to this ARTICLE]
... Obligation for downstream users to report information ...
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-40: Examination of testing proposals [go to this ARTICLE]
... (e) a decision in accordance with points (a), (b) or (c), if several registrants or downstream users of the same substance have submitted proposals for the same test, giving them the opportunity to reach an agreement on who
will perform the test on behalf of all of them and to inform the Agency accordingly within 90 days. If the Agency is not informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users, as appropriate, to perform the test on behalf of all of them. ...
... (e) a decision in accordance with points (a), (b) or (c), if several registrants or downstream users of the same substance have submitted proposals for the same test, giving them the opportunity to reach an agreement on who
will perform the test on behalf of all of them and to inform the Agency accordingly within 90 days. If the Agency is not informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users, as appropriate, to perform the test on behalf of all of them. ...
ARTICLE-50: Registrants' and downstream users' rights [go to this ARTICLE]
... Registrants' and downstream users' rights ...
ARTICLE-51: Adoption of decisions under dossier evaluation [go to this ARTICLE]
... 5. The Agency shall forthwith communicate any proposal for amendment to any registrants or downstream users concerned and allow them to comment within 30 days. The Member State Committee shall take any comments received into account.
...
ARTICLE-53: Cost sharing for tests without an agreement between registrants and/or downstream users [go to this ARTICLE]
... Cost sharing for tests without an agreement between registrants and/or downstream users ...
... 1. Where registrants or downstream users are required to perform a test as a result of a decision taken under this Title, those registrants or downstream users shall make every effort to reach an agreement as to who is to carry it out on behalf of the other registrants or downstream users and to inform the Agency accordingly within 90 days. If the Agency is not informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users to perform the test on behalf of all of them. ...
... 1. Where registrants or downstream users are required to perform a test as a result of a decision taken under this Title, those registrants or downstream users shall make every effort to reach an agreement as to who is to carry it out on behalf of the other registrants or downstream users and to inform the Agency accordingly within 90 days. If the Agency is not informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users to perform the test on behalf of all of them. ...
... 1. Where registrants or downstream users are required to perform a test as a result of a decision taken under this Title, those registrants or downstream users shall make every effort to reach an agreement as to who is to carry it out on behalf of the other registrants or downstream users and to inform the Agency accordingly within 90 days. If the Agency is not informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users to perform the test on behalf of all of them. ...
... 1. Where registrants or downstream users are required to perform a test as a result of a decision taken under this Title, those registrants or downstream users shall make every effort to reach an agreement as to who is to carry it out on behalf of the other registrants or downstream users and to inform the Agency accordingly within 90 days. If the Agency is not informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users to perform the test on behalf of all of them. ...
ARTICLE-55: Aim of authorisation and considerations for substitution [go to this ARTICLE]
... The aim of this Title is to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. To this end all manufacturers, importers and downstream users applying for authorisations shall analyse the availability of alternatives and consider their risks, and the technical and
economic feasibility of substitution. ...
ARTICLE-65: Obligation of holders of authorisations [go to this ARTICLE]
... Holders of an authorisation, as well as downstream users referred to in Article 56(2) including the substances in a preparation, shall include the authorisation number on the label before they place the substance or a preparation containing the substance on the market for an authorised use without prejudice
to Directive 67/548/EEC and Directive 1999/45/EC. This shall be done without delay once the authorisation number has been made publicly available in accordance with Article 64(9). ...
ARTICLE-66: Downstream users [go to this ARTICLE]
... Downstream users ...
... 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. ...
... 2. The Agency shall establish and keep up to date a register of downstream users who have made a notification in accordance with paragraph 1. The Agency shall grant access to this register to the competent authorities of the Member States. ...
ARTICLE-111: Formats and software for submission of information to the Agency [go to this ARTICLE]
... The Agency shall specify formats and make them available free of charge, and software packages and make them available on its website for any submissions to the Agency. Member States, manufactures, importers, distributors or downstream users shall use these formats and packages in their submissions to the Agency pursuant to this Regulation. In particular, the Agency shall make available software tools to facilitate the submission of all information relating to substances registered in accordance with Article 12(1). ...
ARTICLE-118: Access to information [go to this ARTICLE]
ARTICLE-124: Other responsibilities [go to this ARTICLE]
... Member States shall establish national helpdesks to provide advice to manufacturers, importers, downstream users and any other interested parties on their respective responsibilities and obligations under this Regulation, in particular
in relation to the registration of substances in accordance with Article 12(1), in addition to the operational guidance documents provided by the Agency under Article 77(2)(g). ...
ARTICLE-I: GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS [go to this ARTICLE]
... Thus the information to be considered includes information related to the hazards of the substance, the exposure arising
from the manufacture or import, the identified uses of the substance, operational conditions and risk management measures applied or recommended to downstream users to be taken into account. ...
... If the manufacturer or importer considers that further information is necessary for producing his chemical safety report and that this information can only
be obtained by performing tests in accordance with Annex IX or X, he shall submit a proposal for a testing strategy, explaining why he considers that additional information is necessary
and record this in the chemical safety report under the appropriate heading. While waiting for results of further testing,
he shall record in his chemical safety report, and include in the exposure scenario developed, the interim risk management measures that he has put in place and those he recommends to downstream users intended to manage the risks being explored. ...
... An exposure scenario is the set of conditions that describe how the substance is manufactured or used during its life-cycle and how the manufacturer
or importer controls, or recommends downstream users to control, exposures of humans and the environment. These sets of conditions contain a description of both the risk management
measures and operational conditions which the manufacturer or importer has implemented or recommends to be implemented by downstream users. ...
... An exposure scenario is the set of conditions that describe how the substance is manufactured or used during its life-cycle and how the manufacturer
or importer controls, or recommends downstream users to control, exposures of humans and the environment. These sets of conditions contain a description of both the risk management
measures and operational conditions which the manufacturer or importer has implemented or recommends to be implemented by downstream users. ...
... 0.13. Part A of the chemical safety report shall include a declaration that the risk management measures outlined in
the relevant exposure scenarios for the manufacturer's or importer's own use(s) are implemented by the manufacturer or importer and that those exposure scenarios for the identified uses are communicated to distributors and downstream users in the safety data sheet(s). ...
... For substances satisfying the PBT and vPvB criteria, the manufacturer or importer shall use the information as obtained in Section 5, Step 2 when implementing on its site, and recommending for downstream users, risk management measures which minimise exposures and emissions to humans and the environment, throughout the lifecycle
of the substance that results from manufacture or identified uses. ...
ARTICLE-VI: INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10 [go to this ARTICLE]
... 3.4. Form (substance, preparation or article) and/or physical state under which the substance is made available to downstream users. Concentration or concentration range of the substance in preparations made available to downstream users and quantities of the substance in articles made available to downstream users. ...
... 3.4. Form (substance, preparation or article) and/or physical state under which the substance is made available to downstream users. Concentration or concentration range of the substance in preparations made available to downstream users and quantities of the substance in articles made available to downstream users. ...
... 3.4. Form (substance, preparation or article) and/or physical state under which the substance is made available to downstream users. Concentration or concentration range of the substance in preparations made available to downstream users and quantities of the substance in articles made available to downstream users. ...
ARTICLE-XII: GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS [go to this ARTICLE]
... GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS ...
... 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. ...
ARTICLE-XV: DOSSIERS [go to this ARTICLE]
... The socio-economic impacts of the proposed restriction may be analysed with reference to Annex XVI. To this end, the net benefits to human health and the environment of the proposed restriction may be compared to its net costs to manufacturers, importers, downstream users, distributors, consumers and society as a whole. ...
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,
...
ARTICLE-FOOTNOTES: List of Footnotes [go to this ARTICLE]
... [64] This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are required to carry out tests under this Regulation adapted as necessary. ...
... [66] This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are required to carry out tests under this Regulation adapted as necessary. ...
... [68] This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are required to carry out tests under this Regulation adapted as necessary. ...
... [70] This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are required to carry out tests under this Regulation adapted as necessary. ...