- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
Commission Regulation (EU) No 252/2011 of 15 March 2011 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex I (Text with EEA relevance)
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Annex I to Regulation (EC) No 1907/2006 is amended as follows:
point 0.6 is replaced by the following:
Human health hazard assessment.
Human health hazard assessment of physicochemical properties.
Environmental hazard assessment.
PBT and vPvB assessment.
Exposure assessment.
The generation of exposure scenario(s) (or the identification of relevant use and exposure categories, if appropriate).
Exposure estimation.
Risk characterisation.
hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, and 2.15 types A to F;
hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9, and 3.10;
hazard class 4.1;
hazard class 5.1.
point 1.0.1 is replaced by the following:
point 1.0.2 is replaced by the following:
acute effects such as acute toxicity, irritation and corrosivity;
sensitisation;
repeated dose toxicity; and
CMR effects (carcinogenity, germ cell mutagenicity and toxicity for reproduction).
Based on all the available information, other effects shall be considered when necessary.’;
point 1.1.3 is replaced by the following:
points 1.3.1 and 1.3.2 are replaced by the following:
The assessment should always include a statement as to whether the substance fulfils or does not fulfil the criteria given in Regulation (EC) No 1272/2008 for classification in the hazard class carcinogenicity category 1A or 1B, in the hazard class germ cell mutagenicity category 1A or 1B or in the hazard class reproductive toxicity category 1A or 1B.
the second sentence of point 1.4.1 is replaced by the following:
‘For some hazard classes, especially germ cell mutagenicity and carcinogenicity, the available information may not enable a toxicological threshold, and therefore a DNEL, to be established.’;
point 2.1 is replaced by the following:
point 2.2 is replaced by the following:
explosivity,
flammability,
oxidising potential.
If the information is inadequate to decide whether a substance should be classified for a particular hazard class or category, the registrant shall indicate and justify the action or decision he has taken as a result.’;
point 2.5 is replaced by the following:
point 3.0.1 is replaced by the following:
points 3.2.1 and 3.2.2 are replaced by the following:
points 4.1 and 4.2 are replaced by the following:
This part of the PBT and vPvB assessment shall entail the comparison of the available information with the criteria given in Section 1 of Annex XIII and a statement of whether the substance fulfils or does not fulfil the criteria. The assessment shall be conducted in accordance with the provisions laid down in the introductory part of Annex XIII as well as Sections 2 and 3 of that Annex.
If the substance fulfils the criteria or it is considered as if it is a PBT or vPvB in the registration dossier an emission characterisation shall be conducted comprising the relevant parts of the exposure assessment as described in Section 5. In particular it shall contain an estimation of the amounts of the substance released to the different environmental compartments during all activities carried out by the manufacturer or importer and all identified uses, and an identification of the likely routes by which humans and the environment are exposed to the substance.’;
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