Registration, Evaluation, Authorisation and Restriction of Chemicals

02006R1907-20150101 → 02006R1907-20150323

ANNEX I GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS 0. INTRODUCTION 0.1. The purpose of this Annex is to set out how manufacturers and importers are to assess and document that the risks arising from the substance they manufacture or … 5,379 unchanged words … sewage treatment systems 10.2. (Title of exposure scenario 2) 10.2.1. Human health 10.2.1.1. Workers 10.2.1.2. Consumers 10.2.1.3. Indirect exposure to humans via the environment 10.2.2. Environment 10.2.2.1. Aquatic compartment (including sediment) 10.2.2.2. Terrestrial compartment 10.2.2.3. Atmospheric compartment 10.2.2.4. Microbiological activity in sewage treatment systems (etc.) 10.x. Overall exposure (combined for all relevant emission/release emissionelease sources) 10.x.1. Human health (combined for all exposure routes) 10.x.1.1. 10.x.2. Environment (combined for all emission sources) 10.x.2.1.

02006R1907-20150101 → 02006R1907-20150323

ANNEX VIII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MOREThis Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are … 1,337 unchanged words … are implemented, or the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented, or relevant human exposure can be excluded in accordance with Annex XI section 3, or a pre-natal developmental toxicity study (Annex IX, 8.7.2) or, either an Extended One-Generation Reproductive Toxicity Study (B.56, OECD TG 443) (Annex IX, section 8.7.3) or a two-generation reproductive toxicity study (Annex IX, Section 8.7.3) (B.35, OECD TG 416), is available. If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment, then no further testing for fertility will be necessary. However, testing for developmental toxicity must be considered. If a substance is known to cause developmental toxicity, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage the unborn child (H360D), and the available data are adequate to support a robust risk assessment, then no further testing for developmental toxicity will be necessary. However, testing for effects on fertility must be considered. In cases where there are serious concerns about the potential for adverse effects on fertility or development, either an Extended One-Generation Reproductive Toxicity Study (Annex IX, section 8.7.3) or a pre-natal developmental toxicity study (Annex IX, Section section 8.7.2) or a two-generation reproductive toxicity study (Annex IX, Section 8.7.3) may may, as appropriate, be proposed by the registrant instead of the screening study. 8.8. Toxicokinetics 8.8.1. Assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information 9. ECOTOXICOLOGICAL INFORMATION COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES … 326 unchanged words … need to be conducted if: based on the physicochemical properties the substance can be expected to have a low potential for adsorption (e.g. the substance has a low octanol water partition coefficient), or the substance and its relevant degradation products decompose rapidly.

02006R1907-20150101 → 02006R1907-20150323

ANNEX IX STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MOREThis Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are … 1,361 unchanged words … performed on one species. A decision on the need to perform a study at this tonnage level or the next on a second species should be based on the outcome of the first test and all other relevant available data. 8.7.3. Two-generation reproductive toxicity study, Extended One-Generation Reproductive Toxicity Study (B.56 of the Commission Regulation on test methods as specified in Article 13(3) or OECD 443), basic test design (cohorts 1A and 1B without extension to include a F2 generation), one species, male and female, most appropriate route of administration, having regard to the likely route of human exposure, if the available repeated dose toxicity studies (e.g. 28-day or 90-day study indicates studies, OECD 421 or 422 screening studies) indicate adverse effects on reproductive organs or tissues. tissues or reveal other concerns in relation with reproductive toxicity. 8.7.3. An Extended One-Generation Reproductive Toxicity Study with the extension of cohort 1B to include the F2 generation shall be proposed by the registrant or may be required by the Agency in accordance with Article 40 or 41, if: (a) the substance has uses leading to significant exposure of consumers or professionals, taking into account, inter alia, consumer exposure from articles, and (b) any of the following conditions are met: the substance displays genotoxic effects in somatic cell mutagenicity tests in vivo which could lead to classifying it as Mutagen Category 2, or there are indications that the internal dose for the substance and/or any of its metabolites will reach a steady state in the test animals only after an extended exposure, or there are indications of one or more relevant modes of action related to endocrine disruption from available in vivo studies or non-animal approaches. An Extended One-Generation Reproductive Toxicity Study including cohorts 2A/2B (developmental neurotoxicity) and/or cohort 3 (developmental immunotoxicity) shall be proposed by the registrant or may be required by the Agency in accordance with Article 40 or 41, in case of particular concerns on (developmental) neurotoxicity or (developmental) immunotoxicity justified by any of the following: existing information on the substance itself derived from relevant available in vivo or non-animal approaches (e.g. abnormalities of the CNS, evidence of adverse effects on the nervous or immune system in studies on adult animals or animals exposed prenatally), or specific mechanisms/modes of action of the substance with an association to (developmental) neurotoxicity and/or (developmental) immunotoxicity (e.g. cholinesterase inhibition or relevant changes in thyroidal hormone levels associated to adverse effects), or existing information on effects caused by substances structurally analogous to the substance being studied, suggesting such effects or mechanisms/modes of action. Other studies on developmental neurotoxicity and/or developmental immunotoxicity instead of cohorts 2A/2B (developmental neurotoxicity) and/or cohort 3 (developmental immunotoxicity) of the Extended One-Generation Reproductive Toxicity Study may be proposed by the registrant in order to clarify the concern on developmental toxicity. Two-generation reproductive toxicity studies (B.35, OECD TG 416) that were initiated before 13 March 2015 shall be considered appropriate to address this standard information requirement. The study shall be initially performed on one species. A decision on the The need to perform a study at this tonnage level or the next on a second strain or a second species may be considered and a decision should be based on the outcome of the first test and all other relevant available date. data. 9. ECOTOXICOLOGICAL INFORMATION COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 9.1. Aquatic toxicity 9.1. Long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate … 472 unchanged words … 10. METHODS OF DETECTION AND ANALYSIS Description of the analytical methods shall be provided on request, for the relevant compartments for which studies were performed using the analytical method concerned. If the analytical methods are not available this shall be justified.

02006R1907-20150101 → 02006R1907-20150323

ANNEX X STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1000 TONNES OR MOREThis Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are … 925 unchanged words … no further testing for developmental toxicity will be necessary. However, testing for effects on fertility must be considered. 8.7.2. Developmental toxicity study, one species, most appropriate route of administration, having regard to the likely route of human exposure (OECD 414). 8.7.3. Two-generation reproductive toxicity study, Extended One-Generation Reproductive Toxicity Study (B.56 of the Commission Regulation on test methods as specified in Article 13(3) or OECD 443), basic test design (cohorts 1A and 1B without extension to include a F2 generation), one species, male and female, most appropriate route of administration, having regard to the likely route of human exposure, unless already provided as part of Annex IX requirements requirements. 8.7.3. An Extended One-Generation Reproductive Toxicity Study with the extension of cohort 1B to include the F2 generation shall be proposed by the registrant or may be required by the Agency in accordance with Article 40 or 41, if: (a) the substance has uses leading to significant exposure of consumers or professionals, taking into account, inter alia, consumer exposure from articles, and (b) any of the following conditions are met: the substance displays genotoxic effects in somatic cell mutagenicity tests in vivo which could lead to classifying it as Mutagen Category 2, or there are indications that the internal dose for the substance and/or any of its metabolites will reach a steady state in the test animals only after an extended exposure, or there are indications of one or more relevant modes of action related to endocrine disruption from available in vivo studies or non-animal approaches. An Extended One-Generation Reproductive Toxicity Study including cohorts 2A/2B (developmental neurotoxicity) and/or cohort 3 (developmental immunotoxicity) shall be proposed by the registrant or may be required by the Agency in accordance with Article 40 or 41, in case of particular concerns on (developmental) neurotoxicity or (developmental) immunotoxicity justified by any of the following: existing information on the substance itself derived from relevant available in vivo or non-animal approaches (e.g. abnormalities of the CNS, evidence of adverse effects on the nervous or immune system in studies on adult animals or animals exposed prenatally), or specific mechanisms/modes of action of the substance with an association to (developmental) neurotoxicity and/or (developmental) immunotoxicity (e.g. cholinesterase inhibition or relevant changes in thyroidal hormone levels associated to adverse effects), or existing information on effects caused by substances structurally analogous to the substance being studied, suggesting such effects or mechanisms/modes of action. Other studies on developmental neurotoxicity and/or developmental immunotoxicity instead of cohorts 2A/2B (developmental neurotoxicity) and/or cohort 3 (developmental immunotoxicity) of the Extended One-Generation Reproductive Toxicity Study may be proposed by the registrant in order to clarify the concern on developmental toxicity. Two-generation reproductive toxicity studies (B.35, OECD TG 416) that were initiated before 13 March 2015 shall be considered appropriate to address this standard information requirement. 8.9.1. Carcinogenicity study 8.9.1. A carcinogenicity study may be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if: the substance has a widespread dispersive use or there is evidence of frequent … 417 unchanged words … level. 10. METHODS OF DETECTION AND ANALYSIS Description of the analytical methods shall be provided on request, for the relevant compartments for which studies were performed using the analytical method concerned. If the analytical methods are not available this shall be justified.

02006R1907-20150101 → 02006R1907-20150323

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ANNEX XVII RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, MIXTURES AND ARTICLES For substances which have been incorporated in this Annex as a consequence of restrictions adopted in the framework of Directive 76/769/EEC (Entries 1 to 58), the restrictions shall not apply to storage, keeping, treatment, filling into containers, or transfer from one container to another of these substances for export, unless the manufacture of the substances is prohibited. … 549 unchanged lines … CAS No 53-70-3 1. From 1 January 2010, extender oils shall not be placed on the market, or used for the production of tyres or parts of tyres if they contain: more than 1 mg/kg (0,0001 % by weight) BaP, or, more than 10 mg/kg (0,001 % by weight) of the sum of all listed PAHs. These limits shall be regarded as kept, if the polycyclic aromatics (PCA) extract is less than 3 % by weight as measured by the Institute of Petroleum standard IP346: 1998 (Determination of PCA in unused lubricating base oils and asphaltene free petroleum fractions — Dimethyl sulphoxide extraction refractive index method), provided that compliance with the limit values of BaP and of the listed PAHs, as well as the correlation of the measured values with the PCA extract, is controlled by the manufacturer or importer every six months or after each major operational change, whichever is earlier. The standard EN 16143:2013 (Petroleum products — Determination of content of Benzo(a)pyrene (BaP) and selected polycyclic aromatic hydrocarbons (PAH) in extender oils — Procedure using double LC cleaning and GC/MS analysis) shall be used as the test method for demonstrating conformity with the limits referred to in the first subparagraph. Until 23 September 2016, the limits referred to in the first subparagraph may be regarded as kept, if the polycyclic aromatics (PCA) extract is less than 3 % by weight as measured by the Institute of Petroleum standard IP 346:1998 (Determination of PCA in unused lubricating base oils and asphaltene free petroleum fractions — Dimethyl sulphoxide extraction refractive index method), provided that compliance with the limits of BaP and of the listed PAHs, as well as the correlation of the measured values with the PCA extract, is measured by the manufacturer or importer every six months or after each major operational change, whichever is earlier. 2. Furthermore, tyres and treads for retreading manufactured after 1 January 2010 shall not be placed on the market if they contain extender oils exceeding the limits indicated in paragraph 1. These limits shall be regarded as kept, if the vulcanised rubber compounds do not exceed the limit of 0,35 % Bay protons as measured and calculated by ISO 21461 (Rubber vulcanised — Determination of aromaticity of oil in vulcanised rubber compounds). 3. By way of derogation, paragraph 2 shall not apply to retreaded tyres if their tread does not contain extender oils exceeding the limits referred to in paragraph 1. … 3,083 unchanged lines … (b) Perboric acid (H3BO2(O2)), monosodium salt trihydrate; perboric acid, sodium salt, tetrahydrate; perboric acid (HBO(O2)), sodium salt, tetrahydrate; sodium peroxoborate hexahydrate CAS No 13517-20-9; 37244-98-7; 10486-00-7 EC No 239-172-9; 234-390-0; 231-556-4 Detergents as defined by Regulation (EC) No 648/2004 of the European Parliament and of the Council. The derogation shall apply until 1 June 2013.