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persistent


PREAMBLE: REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals     [go to this PREAMBLE]
... (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. ...
... (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. ...


ARTICLE-14: Chemical safety report and duty to apply and recommend risk reduction measures     [go to this ARTICLE]
... (d) persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment. ...
... (d) persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment. ...


ARTICLE-31: Requirements for safety data sheets     [go to this ARTICLE]
... (b) where a substance is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII; or ...
... (b) where a substance is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII; or ...
... (b) in an individual concentration of ≥ 0,1 % by weight for non-gaseous preparations at least one substance that is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII or has been included for reasons other than those referred to in point (a) in the list established in accordance with Article 59(1); or ...
... (b) in an individual concentration of ≥ 0,1 % by weight for non-gaseous preparations at least one substance that is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII or has been included for reasons other than those referred to in point (a) in the list established in accordance with Article 59(1); or ...


ARTICLE-44: Criteria for substance evaluation     [go to this ARTICLE]
... (a) hazard information, for instance structural similarity of the substance with known substances of concern or with substances which are persistent and liable to bio-accumulate, suggesting that the substance or one or more of its transformation products has properties of concern or is persistent and liable to bio-accumulate; ...
... (a) hazard information, for instance structural similarity of the substance with known substances of concern or with substances which are persistent and liable to bio-accumulate, suggesting that the substance or one or more of its transformation products has properties of concern or is persistent and liable to bio-accumulate; ...


ARTICLE-57: Substances to be included in Annex XIV     [go to this ARTICLE]
... (d) substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII of this Regulation; ...
... (e) substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII of this Regulation; ...
... (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. ...
... (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-60: Granting of authorisations     [go to this ARTICLE]
... (c) substances identified under Article 57(f) having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties. ...
... (c) substances identified under Article 57(f) having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties. ...


ARTICLE-61: Review of authorisations     [go to this ARTICLE]
... 6. If a use of a substance is subsequently prohibited or otherwise restricted in Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants (51), the Commission shall withdraw the authorisation for that use. ...


... 5. The Commission shall carry out a review of Annex XIII by 1 December 2008, to assess the adequacy of the criteria for identifying substances which are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative, with a view to proposing an amendment to it, if appropriate, in accordance with the procedure referred to in Article 133(4). ...
... 5. The Commission shall carry out a review of Annex XIII by 1 December 2008, to assess the adequacy of the criteria for identifying substances which are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative, with a view to proposing an amendment to it, if appropriate, in accordance with the procedure referred to in Article 133(4). ...


ARTICLE-II: GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS     [go to this ARTICLE]
... (c) substances that are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII, if the concentration of an individual substance is equal to or greater than 0,1 %. ...
... (c) substances that are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII, if the concentration of an individual substance is equal to or greater than 0,1 %. ...
... (b) ≥ 0,1 % by weight and the substances are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII. ...
... (b) ≥ 0,1 % by weight and the substances are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII. ...


ARTICLE-IX: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE [68]     [go to this ARTICLE]
... 9.4.Effects on terrestrial organisms | 9.4.These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.In the absence of toxicity data for soil organisms, the equilibrium partitioning method may be applied to assess the hazard to soil organisms. The choice of the appropriate tests depends on the outcome of the chemical safety assessment.In particular for substances that have a high potential to adsorb to soil or that are very persistent, the registrant shall consider long-term toxicity testing instead of short-term. | ...


ARTICLE-XIII: CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES     [go to this ARTICLE]
... CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES ...
... CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES ...
... (i) persistent, bioaccumulative and toxic substances (PBT-substances), and ...
... (ii) very persistent and very bioaccumulative substances (vPvB-substances). ...