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... 22. The authorisation provisions should ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled. Authorisations for the placing on the market and use should be granted by the Commission only if the risks arising from their use are adequately controlled, where this is possible, or the use can be justified for socio-economic reasons and no suitable alternatives are available, which are economically and technically viable. ...

... 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. ...

... 81. In order to provide a harmonised approach to the authorisation of the uses of particular substances, the Agency should issue opinions on the risks arising from those uses, including whether or not the substance is adequately controlled and on any socio-economic analysis submitted to it by third parties. These opinions should be taken into account by the Commission when considering whether or not to grant an authorisation. ...

... 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. ...

... 117. EU-citizens should have access to information about chemicals to which they may be exposed, in order to allow them to make informed decisions about their use of chemicals. A transparent means of achieving this is to grant them free and easy access to basic data held in the Agency's database, including brief profiles of hazardous properties, labelling requirements and relevant Community legislation including authorised uses and risk management measures. The Agency and Member States should allow access to information in accordance with Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information⁽¹⁶⁾, Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents⁽¹⁷⁾ and with the UNECE Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters, to which the European Community is a party. ...

... (i) any change in the access granted to information in the registration. ...

... (b) once an authorisation has been granted or refused; ...

... (b) if the substance is subject to authorisation and details of any authorisation granted or denied under Title VII in this supply chain; ...

... (b) once an authorisation has been granted or refused; ...

... Workers and their representatives shall be granted access by their employer to the information provided in accordance with Articles 31 and 32 in relation to substances or preparations that they use or may be exposed to in the course of their work. ...

... (e) in cases where the substance is placed on the market, authorisation for that use has been granted to his immediate downstream user. ...

... 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. ...

... (i) the date(s) from which the placing on the market and the use of the substance shall be prohibited unless an authorisation is granted (hereinafter referred to as "the sunset date") which should take into account, where appropriate, the production cycle specified for that use; ...

... 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): ...

... 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): ...

... 7. An authorisation shall be granted only if the application is made in conformity with the requirements of Article 62. ...

... (a) the person(s) to whom the authorisation is granted; ...

... (c) the use(s) for which the authorisation is granted; ...

... (d) any conditions under which the authorisation is granted; ...

... 1. Authorisations granted in accordance with Article 60 shall be regarded as valid until the Commission decides to amend or withdraw the authorisation in the context of a review, provided that the holder of the authorisation submits a review report at least 18 months before the expiry of the time-limited review period. Rather than re-submitting all elements of the original application for the current authorisation, the holder of an authorisation may submit only the number of the current authorisation, subject to the second, third and fourth subparagraphs. A holder of an authorisation granted in accordance with Article 60 shall submit an update of the analysis of alternatives referred to in Article 62(4)(e), including information about any relevant research and development activities by the applicant, if appropriate, and any substitution plan submitted under Article 62(4)(f). If the update of the analysis of alternatives shows that there is a suitable alternative available taking into account the elements in Article 60(5), he shall submit a substitution plan, including a timetable for proposed actions by the applicant. If the holder cannot demonstrate that the risk is adequately controlled, he shall also submit an update of the socio-economic analysis contained in the original application. If he can now demonstrate that the risk is adequately controlled, he shall submit an update of the chemical safety report. If any other elements of the original application have changed, he shall also submit updates of these element(s). When any updated information is submitted in accordance with this paragraph, any decision to amend or withdraw the authorisation in the context of the review shall be taken in accordance with the procedure referred to in Article 64 applied mutatis mutandis. ...

... 1. Authorisations granted in accordance with Article 60 shall be regarded as valid until the Commission decides to amend or withdraw the authorisation in the context of a review, provided that the holder of the authorisation submits a review report at least 18 months before the expiry of the time-limited review period. Rather than re-submitting all elements of the original application for the current authorisation, the holder of an authorisation may submit only the number of the current authorisation, subject to the second, third and fourth subparagraphs. A holder of an authorisation granted in accordance with Article 60 shall submit an update of the analysis of alternatives referred to in Article 62(4)(e), including information about any relevant research and development activities by the applicant, if appropriate, and any substitution plan submitted under Article 62(4)(f). If the update of the analysis of alternatives shows that there is a suitable alternative available taking into account the elements in Article 60(5), he shall submit a substitution plan, including a timetable for proposed actions by the applicant. If the holder cannot demonstrate that the risk is adequately controlled, he shall also submit an update of the socio-economic analysis contained in the original application. If he can now demonstrate that the risk is adequately controlled, he shall submit an update of the chemical safety report. If any other elements of the original application have changed, he shall also submit updates of these element(s). When any updated information is submitted in accordance with this paragraph, any decision to amend or withdraw the authorisation in the context of the review shall be taken in accordance with the procedure referred to in Article 64 applied mutatis mutandis. ...

... 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. ...

... 4. If an environmental quality standard referred to in Directive 96/61/EC is not met, the authorisations granted for the use of the substance concerned may be reviewed. ...

... 5. If the environmental objectives as referred to in Article 4(1) of Directive 2000/60/EC are not met, the authorisations granted for the use of the substance concerned in the relevant river basin may be reviewed. ...

... (i) emissions of a substance from an installation for which a permit was granted in accordance with Directive 96/61/EC; or ...

... 2. If an authorisation has been granted for a use of a substance, a subsequent applicant may refer to the appropriate parts of the previous application submitted in accordance with Article 62(4)(d), (e) and (f) and (5)(a), provided that the subsequent applicant has permission from the holder of the authorisation to refer to these parts of the application. ...

... 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. ...

... 1. A classification and labelling inventory, listing the information referred to in Article 113(1), both for information notified under Article 113(1) as well as for information submitted as part of a registration, shall be established and maintained by the Agency in the form of a database. The information in this database identified in Article 119(1) shall be publicly accessible. The Agency shall grant access to the other data on each substance in the inventory to the notifiers and registrants who have submitted information on that substance in accordance with Article 29(1). The Agency shall update the inventory when it receives updated information in accordance with Article 113(3). ...