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mutagenic


PREAMBLE: REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals     [go to this PREAMBLE]
... (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. ...
... (75) The possibility of introducing restrictions on the manufacturing, placing on the market and use of dangerous substances, preparations and articles applies to all substances falling within the scope of this Regulation, with minor exemptions. Restrictions on the placing on the market and the use of substances which are carcinogenic, mutagenic or toxic to reproduction, category 1 or 2, for their use by consumers on their own or in preparations should continue to be introduced. ...
... (115) Resources should be focused on substances of the highest concern. A substance should therefore be added to Annex I of Directive 67/548/EEC if it meets the criteria for classification as carcinogenic, mutagenic or toxic for reproduction categories 1, 2 or 3, as a respiratory sensitiser, or in respect of other effects on a case-by-case basis. Provision should be made to enable competent authorities to submit proposals to the Agency. The Agency should give its opinion on the proposal while interested parties should have an opportunity to comment. The Commission should take a decision subsequently. ...


ARTICLE-23: Specific provisions for phase-in substances     [go to this ARTICLE]
... (a) phase-in substances classified as carcinogenic, mutagenic or toxic to reproduction, category 1 or 2, in accordance with Directive 67/548/EEC and manufactured in the Community or imported, in quantities reaching one tonne or more per year per manufacturer or per importer, at least once after 1 June 2007; ...


ARTICLE-40: Examination of testing proposals     [go to this ARTICLE]
... 1. The Agency shall examine any testing proposal set out in a registration or a downstream user report for provision of the information specified in Annexes IX and X for a substance. Priority shall be given to registrations of substances which have or may have PBT, vPvB, sensitising and/or carcinogenic, mutagenic or toxic for reproduction (CMR) properties, or substances classified as dangerous according to Directive 67/548/EEC above 100 tonnes per year with uses resulting in widespread and diffuse exposure. ...


ARTICLE-57: Substances to be included in Annex XIV     [go to this ARTICLE]
... (b) substances meeting the criteria for classification as mutagenic category 1 or 2 in accordance with Directive 67/548/EEC; ...


ARTICLE-68: Introducing new and amending current restrictions     [go to this ARTICLE]
... 2. For a substance on its own, in a preparation or in an article which meets the criteria for classification as carcinogenic, mutagenic or toxic to reproduction, category 1 or 2, and could be used by consumers and for which restrictions to consumer use are proposed by the Commission, Annex XVII shall be amended in accordance with the procedure referred to in Article 133(4). Articles 69 to 73 shall not apply. ...


ARTICLE-115: Harmonisation of classification and labelling     [go to this ARTICLE]
... 1. Harmonised classification and labelling at Community level shall, from 1 June 2007, normally be added to Annex I of Directive 67/548/EEC for classification of a substance as carcinogenic, mutagenic or toxic for reproduction category 1, 2 or 3, or as a respiratory sensitiser. Harmonised classification and labelling for other effects may also be added to Annex I of Directive 67/548/EEC on a case-by-case basis if justification is provided demonstrating the need for action at Community level. To this end, Member State competent authorities may submit proposals to the Agency for harmonised classification and labelling in accordance with Annex XV. ...


... 1. By 1 June 2019, the Commission shall carry out a review to assess whether or not to extend the application of the obligation to perform a chemical safety assessment and to document it in a chemical safety report to substances not covered by this obligation because they are not subject to registration or subject to registration but manufactured or imported in quantities of less than 10 tonnes per year. However, for substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction, category 1 or 2, in accordance with Directive 67/548/EEC, the review shall be carried out by 1 June 2014. When carrying out the review the Commission shall take into account all relevant factors, including: ...


ARTICLE-VIII: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE [66]     [go to this ARTICLE]
... 8.4.2.In vitro cytogenicity study in mammalian cells or in vitro micronucleus study | 8.4.2.The study does not usually need to be conductedif adequate data from an in vivo cytogenicity test are available, orthe substance is known to be carcinogenic category 1 or 2 or mutagenic category 1, 2 or 3. | ...


ARTICLE-XIII: CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES     [go to this ARTICLE]
... - the substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2, or 3), or ...


ARTICLE-XVII: RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES     [go to this ARTICLE]
... Substances with specific effects on human health (see chapter 4 of Annex VI of Directive 67/548/EEC) that are classified as carcinogenic, mutagenic and/or toxic for reproduction in categories 1 or 2 are ascribed Note E if they are also classified as very toxic (T+), toxic (T) or harmful (Xn). For these substances, the risk phrases R20, R21, R22, R23, R24, R25, R26, R27, R28, R39, R68 (harmful), R48 and R65 and all combinations of these risk phrases shall be preceded by the word "Also". ...