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... 1. This Regulation should ensure a high level of protection of human health and the environment as well as the free movement of substances, on their own, in preparations and in articles, while enhancing competitiveness and innovation. This Regulation should also promote the development of alternative methods for the assessment of hazards of substances. ...
... 3. A high level of human health and environmental protection should be ensured in the approximation of legislation on substances, with the goal of achieving sustainable development. That legislation should be applied in a non-discriminatory manner whether substances are traded on the internal market or internationally in accordance with the Community's international commitments. ...
... 4. Pursuant to the implementation plan adopted on 4 September 2002 at the Johannesburg World Summit on sustainable development, the European Union is aiming to achieve that, by 2020, chemicals are produced and used in ways that lead to the minimisation of significant adverse effects on human health and the environment. ...
... 7. To preserve the integrity of the internal market and to ensure a high level of protection for human health, especially the health of workers, and the environment, it is necessary to ensure that manufacturing of substances in the Community complies with Community law, even if those substances are exported. ...
... 13. This Regulation should apply without prejudice to the prohibitions and restrictions laid down in Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products(9) in so far as substances are used and marketed as cosmetic ingredients and are within the scope of this Regulation. A phase-out of testing on vertebrate animals for the purpose of protecting human health as specified in Directive 76/768/EEC should take place with regard to the uses of those substances in cosmetics. ...
... 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. ...
... 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. ...
... 20. The evaluation provisions should provide for follow-up to registration, by allowing for checks on whether registrations are in compliance with the requirements of this Regulation and if necessary by allowing for generation of more information on the properties of substances. If the Agency in cooperation with the Member States considers that there are grounds for considering that a substance constitutes a risk to human health or the environment, the Agency should, after having included the substance in the Community rolling action plan for substance evaluation, relying on the competent authorities of Member States, ensure that this substance is evaluated. ...
... 28. Scientific research and development normally takes place in quantities below 1 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. ...
... 29. Since producers and importers of articles should be responsible for their articles, it is appropriate to impose a registration requirement on substances which are intended to be released from articles and have not been registered for that use. In the case of substances of very high concern which are present in articles above tonnage and concentration thresholds, where exposure to the substance cannot be excluded and where the substance has not been registered by any person for this use, the Agency should be notified. The Agency should also be empowered to request that a registration be submitted if it has grounds for suspecting that the release of a substance from the article may present a risk to human health or the environment and the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year. The Agency should consider the need for a proposal for a restriction where it considers that the use of such substances in articles poses a risk to human health or the environment that is not adequately controlled. ...
... 29. Since producers and importers of articles should be responsible for their articles, it is appropriate to impose a registration requirement on substances which are intended to be released from articles and have not been registered for that use. In the case of substances of very high concern which are present in articles above tonnage and concentration thresholds, where exposure to the substance cannot be excluded and where the substance has not been registered by any person for this use, the Agency should be notified. The Agency should also be empowered to request that a registration be submitted if it has grounds for suspecting that the release of a substance from the article may present a risk to human health or the environment and the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year. The Agency should consider the need for a proposal for a restriction where it considers that the use of such substances in articles poses a risk to human health or the environment that is not adequately controlled. ...
... 41. For reasons of workability and because of their special nature, specific registration requirements should be laid down for intermediates. Polymers should be exempted from registration and evaluation until those that need to be registered due to the risks posed to human health or the environment can be selected in a practicable and cost-efficient way on the basis of sound technical and valid scientific criteria. ...
... 50. It is in the public interest to ensure the quickest possible circulation of test results on human health or environmental hazards of certain substances to those natural or legal persons which use them, in order to limit any risks associated with their use. Sharing of information should occur where this is requested by any registrant, in particular in the case of information involving tests on vertebrate animals, under conditions that ensure a fair compensation for the company that has undertaken the tests. ...
... 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. ...
... 69. To ensure a sufficiently high level of protection for human health, including having regard to relevant human population groups and possibly to certain vulnerable sub-populations, and the environment, substances of very high concern should, in accordance with the precautionary principle, be subject to careful attention. Authorisation should be granted where natural or legal persons applying for an authorisation demonstrate to the granting authority that the risks to human health and the environment arising from the use of the substance are adequately controlled. Otherwise, uses may still be authorised if it can be shown that the socio-economic benefits from the use of the substance outweigh the risks connected with its use and there are no suitable alternative substances or technologies that are economically and technically viable. Taking into account the good functioning of the internal market it is appropriate that the Commission should be the granting authority. ...
... 69. To ensure a sufficiently high level of protection for human health, including having regard to relevant human population groups and possibly to certain vulnerable sub-populations, and the environment, substances of very high concern should, in accordance with the precautionary principle, be subject to careful attention. Authorisation should be granted where natural or legal persons applying for an authorisation demonstrate to the granting authority that the risks to human health and the environment arising from the use of the substance are adequately controlled. Otherwise, uses may still be authorised if it can be shown that the socio-economic benefits from the use of the substance outweigh the risks connected with its use and there are no suitable alternative substances or technologies that are economically and technically viable. Taking into account the good functioning of the internal market it is appropriate that the Commission should be the granting authority. ...
... 69. To ensure a sufficiently high level of protection for human health, including having regard to relevant human population groups and possibly to certain vulnerable sub-populations, and the environment, substances of very high concern should, in accordance with the precautionary principle, be subject to careful attention. Authorisation should be granted where natural or legal persons applying for an authorisation demonstrate to the granting authority that the risks to human health and the environment arising from the use of the substance are adequately controlled. Otherwise, uses may still be authorised if it can be shown that the socio-economic benefits from the use of the substance outweigh the risks connected with its use and there are no suitable alternative substances or technologies that are economically and technically viable. Taking into account the good functioning of the internal market it is appropriate that the Commission should be the granting authority. ...
... 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. ...
... 71. Methodologies to establish thresholds for carcinogenic and mutagenic substances may be developed taking into account the outcomes of RIPs. The relevant Annex may be amended on the basis of these methodologies to allow thresholds where appropriate to be used while ensuring a high level of protection of human health and the environment. ...
... 73. Substitution of a substance on its own, in a preparation or in an article should be required when manufacture, use or placing on the market of that substance causes an unacceptable risk to human health or to the environment, taking into account the availability of suitable safer alternative substances and technologies, and the socio-economic benefits from the uses of the substance posing an unacceptable risk. ...
... 76. Experience at international level shows that substances with characteristics rendering them persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, present a very high concern, while criteria have been developed allowing the identification of such substances. For certain other substances concerns are sufficiently high to address them in the same way on a case-by-case basis. The criteria in Annex XIII should be reviewed taking into account the current and any new experience in the identification of these substances and if appropriate, be amended with a view to ensuring a high level of protection for human health and the environment. ...
... 80. The proper interaction between the provisions on authorisation and restriction should be ensured in order to preserve the efficient functioning of the internal market and the protection of human health, safety and the environment. Restrictions that exist when the substance in question is added to the list of substances for which applications for authorisation can be submitted, should be maintained for that substance. The Agency should consider whether the risk from substances in articles is adequately controlled and, if it is not, prepare a dossier in relation to introduction of further restrictions for substances for which the use requires authorisation. ...
... 86. It should be the responsibility of the manufacturer, importer and downstream user to identify the appropriate risk management measures needed to ensure a high level of protection for human health and the environment from the manufacturing, placing on the market or use of a substance on its own, in a preparation or in an article. However, where this is considered to be insufficient and where Community legislation is justified, appropriate restrictions should be laid down. ...
... 87. In order to protect human health and the environment, restrictions on the manufacture, placing on the market or use of a substance on its own, in a preparation or in an article may include any condition for, or prohibition of, the manufacture, placing on the market or use. Therefore it is necessary to list such restrictions and any amendments thereto. ...
... 89. In order to give Member States the opportunity to submit proposals to address a specific risk for human health and the environment, they should prepare a dossier in conformity with detailed requirements. The dossier should set out the justification for Community-wide action. ...
... 91. In order to give the Commission the opportunity to address a specific risk for human health and the environment that needs to be addressed Community wide, it should be able to entrust the Agency with the preparation of a restriction dossier. ...
... 111. It is important to avoid confusion between the mission of the Agency and the respective missions of the European Medicines Agency (EMEA) established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency(13), the European Food Safety Authority (EFSA) established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(14) and the Advisory Committee on Safety, Hygiene and Health Protection at Work set up by the Council Decision of 22 July 2003(15). Consequently, the Agency should establish rules of procedure where cooperation with the EFSA or the Advisory Committee on Safety, Hygiene and Health Protection at Work is necessary. This Regulation should otherwise be without prejudice to the competence conferred on the EMEA, the EFSA and the Advisory Committee on Safety, Hygiene and Health Protection at Work by Community legislation. ...
... 112. In order to achieve the functioning of the internal market for substances on their own or in preparations, while at the same time ensuring a high level of protection for human health and the environment, rules should be established for a classification and labelling inventory. ...
... 122. In order to ensure transparency, impartiality and consistency in the level of enforcement activities by Member States, it is necessary for Member States to set up an appropriate framework for penalties with a view to imposing effective, proportionate and dissuasive penalties for non-compliance, as non-compliance can result in damage to human health and the environment. ...
ARTICLE-1: Aim and scope [go to this ARTICLE]
... 1. The purpose of this Regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. ...
... 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-2: Application [go to this ARTICLE]
... (a) in medicinal products for human or veterinary use within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products(6)and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(7); ...
... (a) in medicinal products for human or veterinary use within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products(6)and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(7); ...
... (i) as a food additive in foodstuffs within the scope of Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption(8); ...
... (a) medicinal products for human or veterinary use, within the scope of Regulation (EC) No 726/2004 and Directive 2001/82/EC and as defined in Directive 2001/83/EC; ...
... (c) medical devices which are invasive or used in direct physical contact with the human body in so far as Community measures lay down provisions for the classification and labelling of dangerous substances and preparations which ensure the same level of information provision and protection as Directive 1999/45/EC; ...
ARTICLE-3: Definitions [go to this ARTICLE]
... 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-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. ...
... (ii) the release of the substance from the articles presents a risk to human health or the environment; ...
ARTICLE-9: Exemption from the general obligation to register for product and process orientated research and development (PPORD) [go to this ARTICLE]
... 7. The Agency may decide to extend the five-year exemption period by a further maximum of five years or, in the case of substances to be used exclusively in the development of medicinal products for human or veterinary use, or for substances that are not placed on the market, for a further maximum of ten years, upon request if the manufacturer or importer or producer of articles can demonstrate that such an extension is justified by the research and development programme. ...
ARTICLE-13: General requirements for generation of information on intrinsic properties of substances [go to this ARTICLE]
... 1. Information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, through the use of alternative methods, for example, in vitro methods or qualitative or quantitative structure-activity relationship models or from information from structurally related substances (grouping or read-across). Testing in accordance with Annex VIII, section 8.6 and 8.7, Annex IX and Annex X may be omitted where justified by information on exposure and implemented risk management measures as specified in Annex XI, section 3. ...
ARTICLE-14: Chemical safety report and duty to apply and recommend risk reduction measures [go to this ARTICLE]
... 5. The chemical safety report need not include consideration of the risks to human health from the following end uses: ...
ARTICLE-17: Registration of on-site isolated intermediates [go to this ARTICLE]
... (d) any available existing information on physicochemical, human health or environmental properties of the intermediate. Where a full study report is available, a study summary shall be submitted; ...
ARTICLE-18: Registration of transported isolated intermediates [go to this ARTICLE]
... (d) any available existing information on physicochemical, human health or environmental properties of the intermediate. Where a full study report is available, a study summary shall be submitted; ...
ARTICLE-22: Further duties of registrants [go to this ARTICLE]
... (e) new knowledge of the risks of the substance to human health and/or the environment of which he may reasonably be expected to have become aware which leads to changes in the safety data sheet or the chemical safety report; (f) any change in the classification and labelling of the substance; ...
ARTICLE-31: Requirements for Safety Data Sheets [go to this ARTICLE]
... (a) in an individual concentration of ≥ 1 % by weight for non-gaseous preparations and ≥ 0,2 % by volume for gaseous preparations at least one substance posing human health or environmental hazards; or ...
... 4. The safety data sheet need not be supplied where dangerous substances or preparations offered or sold to the general public are provided with sufficient information to enable users to take the necessary measures as regards the protection of human health, safety and the environment, unless requested by a downstream user or distributor. ...
ARTICLE-37: Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures [go to this ARTICLE]
... 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. For phase-in substances, the manufacturer, importer or downstream user shall comply with this request and with the obligations laid down in Article 14 before the relevant deadline in Article 23 has expired, provided that the downstream user makes his request at least 12 months before the deadline in question. 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). ...
... (e) the substance is present in a preparation in a concentration lower than any of the concentrations set out in Article 14(2); (f) the downstream user is 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. ...
... 6. Where a downstream user does not prepare a chemical safety report in accordance with paragraph 4(c), he shall consider the use(s) of the substance and identify and apply any appropriate risk management measures needed to ensure that the risks to human health and the environment are adequately controlled. Where necessary, this information shall be included in any safety data sheet prepared by him. ...
... 8. A chemical safety report prepared in accordance with paragraph 4 of this Article need not include consideration of the risks to human health from the end uses set out in Article 14(5). ...
ARTICLE-44: Criteria for substance evaluation [go to this ARTICLE]
... 2. The Agency shall use the criteria in paragraph 1 for the purpose of compiling a draft Community rolling action plan which shall cover a period of three years and shall specify substances to be evaluated each year. Substances shall be included if there are grounds for considering (either on the basis of a dossier evaluation carried out by the Agency or on the basis of any other appropriate source, including information in the registration dossier) that a given substance constitutes a risk to human health or the environment. The Agency shall submit the first draft rolling action plan to the Member States by 1 December 2011. The Agency shall submit draft annual updates to the rolling action plan to the Member States by 28 February each year. The Agency shall adopt the final Community rolling action plan on the basis of an opinion from the Member State Committee set up under Article 76(1)(e) (hereinafter referred to as "the Member State Committee") and shall publish the plan on its website, identifying the Member State who will carry out the evaluation of the substances listed therein as determined according to Article 45. ...
ARTICLE-49: Further information on on-site isolated intermediates [go to this ARTICLE]
... For on-site isolated intermediates that are used in strictly controlled conditions, neither dossier nor substance evaluation shall apply. However, where the competent authority of the Member State in whose territory the site is located considers that a risk to human health or the environment, equivalent to the level of concern arising from the use of substances meeting the criteria in Article 57, arises from the use of an on-site isolated intermediate and that risk is not properly controlled, it may: ...
ARTICLE-50: Registrants' and downstream users' rights [go to this ARTICLE]
... (a) where the competent authority prepares a dossier in accordance with Annex XV concluding that there is a potential long-term risk to human health or the environment justifying the need for further information; ...
ARTICLE-56: General provisions [go to this ARTICLE]
... 5. In the case of substances that are subject to authorisation only because they meet the criteria in Article 57(a), (b) or (c) or because they are identified in accordance with Article 57(f) only because of hazards to human health, paragraphs 1 and 2 of this Article shall not apply to the following uses: ...
ARTICLE-57: Substances to be included in Annex XIV [go to this ARTICLE]
... (f) substances - such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) - for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59. ...
ARTICLE-58: Inclusion of substances in Annex XIV [go to this ARTICLE]
... 2. Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled. In the establishment of such exemptions, account shall be taken, in particular, of the proportionality of risk to human health and the environment related to the nature of the substance, such as where the risk is modified by the physical form. ...
... 2. Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled. In the establishment of such exemptions, account shall be taken, in particular, of the proportionality of risk to human health and the environment related to the nature of the substance, such as where the risk is modified by the physical form. ...
... 5. Subject to paragraph 6, after inclusion of a substance in Annex XIV, this substance shall not be subjected to new restrictions under the procedure outlined in Title VIII covering the risks to human health or the environment from the use of the substance on its own, in a preparation or incorporation of a substance in an article arising from the intrinsic properties specified in Annex XIV. ...
... 6. A substance listed in Annex XIV may be subjected to new restrictions under the procedure outlined in Title VIII covering the risks to human health or the environment from the presence of the substance in (an) article(s). ...
ARTICLE-60: Granting of authorisations [go to this ARTICLE]
... 2. Without prejudice to paragraph 3, an authorisation shall be granted if the risk to human health or the environment from the use of a substance arising from the intrinsic properties specified in Annex XIV is adequately controlled in accordance with section 6.4 of Annex I and as documented in the applicant's chemical safety report, taking into account the opinion of the Committee for Risk Assessment referred to in Article 64(4)(a). When granting the authorisation, and in any conditions imposed therein, the Commission shall take into account all discharges, emissions and losses, including risks arising from diffuse or dispersive uses, known at the time of the decision. The Commission shall not consider the risks to human health arising from the use of a substance in a medical device regulated by Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices(1), Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(2)or Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices(3). ...
... 2. Without prejudice to paragraph 3, an authorisation shall be granted if the risk to human health or the environment from the use of a substance arising from the intrinsic properties specified in Annex XIV is adequately controlled in accordance with section 6.4 of Annex I and as documented in the applicant's chemical safety report, taking into account the opinion of the Committee for Risk Assessment referred to in Article 64(4)(a). When granting the authorisation, and in any conditions imposed therein, the Commission shall take into account all discharges, emissions and losses, including risks arising from diffuse or dispersive uses, known at the time of the decision. The Commission shall not consider the risks to human health arising from the use of a substance in a medical device regulated by Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices(1), Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(2)or Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices(3). ...
... 4. If an authorisation cannot be granted under paragraph 2 or for substances listed in paragraph 3, an authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. This decision shall be taken after consideration of all of the following elements and taking into account the opinions of the Committee for Risk Assessment and the Committee for Socio-economic Analysis referred to in Article 64(4)(a) and (b): ...
... (d) available information on the risks to human health or the environment of any alternative substances or technologies. ...
... (a) whether the transfer to alternatives would result in reduced overall risks to human health and the environment, taking into account the appropriateness and effectiveness of risk management measures; ...
ARTICLE-61: Review of authorisations [go to this ARTICLE]
... (a) the circumstances of the original authorisation have changed so as to affect the risk to human health or the environment, or the socio-economic impact; or ...
... 3. In its review decision the Commission may, if circumstances have changed and taking into account the principle of proportionality, amend or withdraw the authorisation, if under the changed circumstances it would not have been granted or if suitable alternatives in accordance with Article 60(5) become available. In the latter case the Commission shall require the holder of the authorisation to present a substitution plan if he has not already done so as part of his application or update. In cases where there is a serious and immediate risk for human health or the environment, the Commission may suspend the authorisation pending the review, taking into account the principle of proportionality. ...
ARTICLE-62: Applications for authorisations [go to this ARTICLE]
... (d) unless already submitted as part of the registration, a chemical safety report in accordance with Annex I covering the risks to human health and/or the environment from the use of the substance(s) arising from the intrinsic properties specified in Annex XIV; ...
... (b) a justification for not considering risks to human health and the environment arising either from: ...
... 6. The application shall not include the risks to human health arising from the use of a substance in a medical device regulated by Directives 90/385/EEC, 93/42/EEC or 98/79/EC. ...
ARTICLE-64: Procedure for authorisation decisions [go to this ARTICLE]
... (a) Committee for Risk Assessment: an assessment of the risk to human health and/or the environment arising from the use(s) of the substance, including the appropriateness and effectiveness of the risk management measures as described in the application and, if relevant, an assessment of the risks arising from possible alternatives; ...
ARTICLE-67: General provisions [go to this ARTICLE]
... 2. Paragraph 1 shall not apply to the use of substances in cosmetic products, as defined by Directive 76/768/EEC, with regard to restrictions addressing the risks to human health within the scope of that Directive. ...
ARTICLE-68: Introducing new and amending current restrictions [go to this ARTICLE]
... 1. When there is an unacceptable risk to human health or the environment, arising from the manufacture, use or placing on the market of substances, which needs to be addressed on a Community-wide basis, Annex XVII shall be amended in accordance with the procedure referred to in Article 133(4) by adopting new restrictions, or amending current restrictions in Annex XVII, for the manufacture, use or placing on the market of substances on their own, in preparations or in articles, pursuant to the procedure set out in Articles 69 to 73. Any such decision shall take into account the socio-economic impact of the restriction, including the availability of alternatives. The first subparagraph shall not apply to the use of a substance as an on-site isolated intermediate. ...
ARTICLE-69: Preparation of a proposal [go to this ARTICLE]
... 1. If the Commission considers that the manufacture, placing on the market or use of a substance on its own, in a preparation or in an article poses a risk to human health or the environment that is not adequately controlled and needs to be addressed, it shall ask the Agency to prepare a dossier which conforms to the requirements of Annex XV. ...