Activities of Julie GIRLING related to 2009/0076(COD)
Plenary speeches (2)
Placing on the market and use of biocidal products (debate)
Placing on the market and use of biocidal products (debate)
Amendments (93)
Amendment 102 #
Council position
Recital 9
Recital 9
(9) This Regulation should apply to biocidal products that, in the form in which they are supplied to the user, consist of, contain or generate one or more active substances. It therefore should not apply to devices within industrial plants that generate biocidal products in situ.
Amendment 113 #
Council position
Article 2 – paragraph 2 – point j a (new)
Article 2 – paragraph 2 – point j a (new)
(j a) Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food. 1 __________________ 1 OJ L 338, 13.11.2004, p. 4.
Amendment 117 #
Proposal for a regulation
Recital 33 a (new)
Recital 33 a (new)
33a. Infestation with harmful organisms should be avoided by means of suitable deterrents to banish or repel these organisms. In addition, other precautionary steps should be taken, e.g. proper warehousing of goods, compliance with hygiene standards and immediate disposal of waste. Only if these measures have no effect should further steps be taken. Biocidal products that pose lower risks for humans, animals and the environment should always be used prior to other products where those lower risk products provide an effective remedy in particular situations. Biocidal products that are intended to harm, kill or destroy animals that are capable of experiencing pain and distress should be applied as a last resort.
Amendment 126 #
Proposal for a regulation
Recital 66
Recital 66
(66) Taking into consideration that some products were not previously covered by the Community legislation in the field of biocidal products, it is appropriate to allow for a transitional period for the companies to be prepared to apply the rules concerning in situ generated active substances, and treated articles and materials and food contact materials.
Amendment 127 #
Council position
Article 3 – paragraph 1 – point ad
Article 3 – paragraph 1 – point ad
(ad) ‘major change’ means an amendment of an existing authorisation which is neither an administrative change nor a minor changerequiring a full or substantial re-evaluation of the risk assessment of the biocidal product or biocidal product family;
Amendment 130 #
Proposal for a regulation
Article 2 – paragraph 2 – point p a (new)
Article 2 – paragraph 2 – point p a (new)
pa. Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC;
Amendment 142 #
Proposal for a regulation
Article 3 – paragraph 1 – point s
Article 3 – paragraph 1 – point s
Amendment 147 #
Proposal for a regulation
Article 3 – paragraph 1 – point u a (new)
Article 3 – paragraph 1 – point u a (new)
ua. 'Administrative change' means a variation to an existing authorisation of a purely administrative nature, which does not involve a re-assessment of the risk for public health or the environment or the efficacy of the product.
Amendment 148 #
Proposal for a regulation
Article 3 – paragraph 1 – point u b (new)
Article 3 – paragraph 1 – point u b (new)
ub. 'Minor change' means a variation to an existing authorisation which cannot be deemed to be an administrative variation as it requires a limited re-assessment of the risk for public health or the environment and/or of the efficacy of the product. The variation should not adversely affect the level of risk for public health or the environment and the efficacy of the product.
Amendment 149 #
Proposal for a regulation
Article 3 – paragraph 1 – point u c (new)
Article 3 – paragraph 1 – point u c (new)
uc. 'Major change' means a variation to an existing authorisation which cannot be deemed to be an administrative change or a minor change.
Amendment 163 #
Council position
Article 17 – paragraph 1 a (new)
Article 17 – paragraph 1 a (new)
1 a. In situ devices shall not be made available on the market unless the biocidal product that they generate is authorised in accordance with this Regulation and the in situ device complies with any relevant conditions of that authorisation.
Amendment 169 #
Council position
Article 18 – paragraph 2 – point d
Article 18 – paragraph 2 – point d
(d) cumulative and synergistic effects.
Amendment 170 #
Council position
Article 18 – paragraph 2 – point d a (new)
Article 18 – paragraph 2 – point d a (new)
(d a) synergistic effects.
Amendment 191 #
Council position
Article 23
Article 23
The Commission shall draw up technical guidance notes to facilitate the implementation of this Chapter and, in particular, Articles 18(2)(d) and (da), 21(2) and 22(3).
Amendment 210 #
Proposal for a regulation
Article 9 – paragraph 1 – point f a (new)
Article 9 – paragraph 1 – point f a (new)
fa) for the uses specified in the dossier of the active substance, an alternative authorised biocidal product or a non- chemical control or prevention method already exists which presents significantly lower risk for human or animal health or the environment;
Amendment 232 #
Council position
Article 40
Article 40
A Union authorisation issued by the Commission in accordance with this Section shall be valid throughout the Union unless otherwise specified. It shall confer the same rights and obligations in each Member State as a national authorisation. For those categories of biocidal products referred to in Article 41(1), the applicant may apply for Union authorisation as an alternative to applying for a national authorisation and mutual recognition.
Amendment 233 #
Council position
Article 41
Article 41
1. Applicants may apply for Union authorisation for biocidal products which have similar conditions of use across the Union and which fall within the following categories of biocidal products: (a) biocidal products of product-types 6, 7, 9, 10, 12, 13 and 22; and (b) with effect from 1 January 2020, all other biocidal products except for those of product-types 14, 15, 17, 20 and 21. 2. The Commission shall report to the European Parliament and the Council on the application of this Article by 31 December 2017. It shall, if appropriate, accompany its report with relevant proposals for adoption in accordance with the ordinary legislative procedure Union authorisation may be granted to all categories of biocidal products with the exception of biocidal products that contain active substances that fall under Article 5.
Amendment 258 #
Council position
Article 57 – paragraph 3 – introductory part
Article 57 – paragraph 3 – introductory part
3. Where, in order to exert a biocidal effect with the exception of in-can preservatives, the release of the active substances contained in the biocidal products with which a treated article was treated or which it incorporates, is intended or expected under normal or reasonably foreseeable conditions of use, the person responsible for the placing on the market of that treated article shall ensure that the label provides the following information:
Amendment 261 #
Council position
Article 57 – paragraph 3 – subparagraph 1a (new)
Article 57 – paragraph 3 – subparagraph 1a (new)
Points (a) to (c) of subparagraph 1 shall not apply where labelling requirements for biocidal products or alternative means to meet information requirements concerning those active substances already exist under sector-specific legislation.
Amendment 263 #
Council position
Article 57 – paragraph 4 – subparagraph 2 a (new)
Article 57 – paragraph 4 – subparagraph 2 a (new)
This paragraph shall not apply where labelling requirements for biocidal products or alternative means to meet information requirements concerning those active substances already exist under sector-specific legislation.
Amendment 277 #
Council position
Article 64 – paragraph 4 a (new)
Article 64 – paragraph 4 a (new)
4a. The Commission shall review the suitability of the definition of nanomaterial for biocides as defined in Article 3 (aa) within two years of the entry into force of this Regulation and shall report to the European Parliament and the Council.
Amendment 283 #
Proposal for a regulation
Article 20 – paragraph 3 – point b
Article 20 – paragraph 3 – point b
b) the permitted alteration of the composition of this reference biocidal product expressed inas reduction in the percentage of the active substance(s) and/or as alteration in the percentage of the non-active substances contained in the biocidal products which are considered to belong to that frame formulation;
Amendment 285 #
Proposal for a regulation
Article 20 – paragraph 3 a (new)
Article 20 – paragraph 3 a (new)
3a. In the case of a frame formulation, one single authorisation number will be provided for all biocidal products which belong to that frame.
Amendment 296 #
Council position
Article 68 – paragraph 2 – subparagraph 1 – introductory part
Article 68 – paragraph 2 – subparagraph 1 – introductory part
In addition to compliance with paragraph 1, authorisation holders shall ensure that labels are not misleading in respect of the risks from the product to human health or the environment or its efficacy and, in any case, do not mention the indications ‘low- risk biocidal product’, ‘non-toxic’, ‘harmless’, ‘natural’, ‘environmentally friendly’, ‘animal friendly’ or similar indications. In addition, the label must show clearly and indelibly the following information:
Amendment 300 #
Council position
Article 71 – paragraph 3
Article 71 – paragraph 3
3. Advertisements for biocidal products shall not refer to the product in a manner which is misleading in respect of the risks from the product to human health or the environment or its efficacy. In any case, the advertising of a biocidal product shall not mention ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’, ‘natural’, ‘environmentally friendly’, ‘animal friendly’ or any similar indication.
Amendment 320 #
8.7. Acute toxicity In addition to the oral route (8.7.1), for substances other than gases, the information mentioned under 8.7.2 to 8.7.3 shallmay be provided for at least one other routes. – The choice for the second route will depend on the nature of the substance and the likely route of human exposure. – Gases and volatile liquids should be administered by the inhalation route – If the only route of exposure is the oral route, then information for only that route need be provided. If dermal or inhalation route is the only route available then an oral test may be considered. Before a new dermal acute toxicity study is carried out, an in vitro dermal penetration study (OECD 428) should be conducted to assess the likely magnitude and rate of dermal bioavailability. – There may be specificexceptional circumstances where all routes of exposure are deemed necessary.
Amendment 321 #
8.7.3. By dermal route Testing by the dermal route is approprimay be indicated if: – inhalation of the substance is unlikely; or – skin contact in production and/or use is likely; or – the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin; and – the oral LD50 is 300 mg/kg or less; – the results of an in vitro dermal penetration study (OECD 428) demonstrate high dermal bioavailability.
Amendment 323 #
Council position
Annex II – Title 1 – 8.9.3. Long-term repeated dose toxicity (≥ 12 months) – Column 3
Annex II – Title 1 – 8.9.3. Long-term repeated dose toxicity (≥ 12 months) – Column 3
8.9.3. The long-term toxicity study (≥ 12 months) does not need to be conducted if: – Long-term exposure can be excluded and no effects have been seen at limit dose in the 90-day study, or – if the application of an uncertainty factor of up to ten-fold would be sufficiently protective for risk assessment purposes, or – a combined long-term repeated dose/carcinogencity study (section 8.11.1) is undertaken.
Amendment 324 #
Council position
Annex II – Title 1 – 8.9.4. Further repeat dose studies – Column 1– paragraph 1 – introductory part and indent 1
Annex II – Title 1 – 8.9.4. Further repeat dose studies – Column 1– paragraph 1 – introductory part and indent 1
8.9.4. Further repeat dose studies Further repeat dose studies including testing on a second species (non-rodent), studies of longer duration or through a different route of exposure shallmay be undertaken in case of: – no other information on toxicity for a second non-rodent species is provided for; or
Amendment 326 #
Council position
Annex II – Title 1 – 8.11.2. Carcinogenicity testing in a second species – Column 1
Annex II – Title 1 – 8.11.2. Carcinogenicity testing in a second species – Column 1
Amendment 329 #
8.13.3. Endocrine disruption-mediated toxicity If there is any evidence from in vitro, repeat dose or reproduction toxicity studies, that the active substance may haveexhibit endocrine disrupting-mediated toxic properties then additional information or specific studies shallmay be required:
Amendment 330 #
Council position
Annex II – Title 1 – 8.13.4. – Column 1
Annex II – Title 1 – 8.13.4. – Column 1
8.13.4. Immunotoxicity including developmental immunotoxicity If there is any evidence, from skin sensitisation, repeat dose or reproduction toxicity studies, that the active substance may have immunotoxicity properties then additional information or specific studies shallmay be required: – to elucidate the mode/mechanism of action – provide sufficient evidence for relevant adverse effects in humans
Amendment 332 #
Council position
Annex II – Title 1 – 9.9. – Column 3 (new)
Annex II – Title 1 – 9.9. – Column 3 (new)
Data are derived from the mammalian toxicological assessment. The most sensitive relevant mammalian long-term toxicological endpoint (NOAEL) expressed as mg test compound/kg bw/day shall be reported.
Amendment 333 #
Council position
Annex II – Title 2 – 7. Effects on human and animal health – Column 3 (new)
Annex II – Title 2 – 7. Effects on human and animal health – Column 3 (new)
Information requirements in this section may be adapted as appropriate in accordance with the specifications of Title 1 of this Annex.
Amendment 334 #
Council position
Annex II – Title 2 – 7.2.2.2. Acute inhalatory toxicity– Column 2 (new)
Annex II – Title 2 – 7.2.2.2. Acute inhalatory toxicity– Column 2 (new)
ADS
Amendment 335 #
Council position
Annex II – Title 2– 7.2.2.3. Intraperitoneal/subcutaneous single dose – Column 2 (new)
Annex II – Title 2– 7.2.2.3. Intraperitoneal/subcutaneous single dose – Column 2 (new)
ADS
Amendment 336 #
Council position
Annex II – Title 2 – 8. Effects on non-target organisms – Column 3 (new)
Annex II – Title 2 – 8. Effects on non-target organisms – Column 3 (new)
Information requirements in this section may be adapted as appropriate in accordance with the specifications of Title 1 of this Annex.
Amendment 338 #
Proposal for a regulation
Article 33 – paragraph 1 – point b a (new)
Article 33 – paragraph 1 – point b a (new)
b a) biocidal products designed to be used by consumers in domestic settings, or by professional users, according to conditions and instructions of use which are similar within the European Union, and which meet the criteria listed in Article 33 a (new).
Amendment 340 #
Council position
Annex III – Title 1 – 8.5.3. Acute toxicity – by dermal route – Column 1
Annex III – Title 1 – 8.5.3. Acute toxicity – by dermal route – Column 1
Amendment 341 #
Council position
Annex III – Title 1 – 9.1. Testing of biocide formulations – Column 1 – indent 2
Annex III – Title 1 – 9.1. Testing of biocide formulations – Column 1 – indent 2
- Where valid datainformation on the components is not available or where synergistic effects may be expected then, testing of components and/or the biocidal product itself may be necessary. Vertebrate animal testing should be restricted to acute studies.
Amendment 343 #
Council position
Annex III – Title 2 – 8.5.3. Acute toxicity – by dermal route – Column 1
Annex III – Title 2 – 8.5.3. Acute toxicity – by dermal route – Column 1
Amendment 345 #
8.7. Available toxicological data relating to: – co-formulants (i.e. substance(s) of concern), or – a mixture that a substance(s) of concern is a component of – Iif noinsufficient data isare available, then for a co- formulant(s) and cannot be inferred through read-across or other appropriaccepted non-testing approaches, targeted test(s) described in Annex II, shall be carried out for the co-formulants (i.e. substance(s) of concern) or a mixture that a substance(s) of concern is a component of. Vertebrate animal testing should be restricted to acute studies.
Amendment 345 #
Proposal for a regulation
Article 33 a (new)
Article 33 a (new)
Amendment 346 #
Council position
Annex III – Title 2 – 9.2. Testing of biocide formulations – Column 1
Annex III – Title 2 – 9.2. Testing of biocide formulations – Column 1
9.2. Further ecotoxicological studies Further studies chosen from among the endpoints referred to in Annex II, Section 8, Micro- Organisms for relevant components of the biocidal product or the biocidal product itself may be required if the data on the active substance cannot give sufficient information and if there are indications of risk due to specific properties of the biocidal product. Vertebrate animal testing should be restricted to acute studies.
Amendment 349 #
Council position
Annex VI – Introduction – point 2
Annex VI – Introduction – point 2
2. The principles set out in this Annex can be applied in their entirety to the evaluation of biocidal products comprised of chemical substances. For biocidal products containing micro-organisms, these principles should be further developed in technical guidance taking into account practical experience gained, and be applied taking into account the nature of the product and the latest scientific information. In the case of biocidal products containing nanomaterials the principles set out in this Annex will also need to be adapted and elaborated in technical guidance to take account of the latest scientific information. The guidance, for substances falling under Recommendation 20../…/EC of … shall not apply where these substances contain: - less than 10 wt-% of nano-objects OR - less than 50 wt-% of aggregates /agglomerates consisting of nano-objects OR - have not been intentionally manufactured at the nanoscale in order to take advantage of their specific nano qualities
Amendment 352 #
Council position
Annex VI– Introduction – point 3
Annex VI– Introduction – point 3
3. In order to ensure a high and harmonised level of protection of human and animal health and of the environment, any risks arising from the use of a biocidal product shall be identified. To achieve this, a risk assessment shall be carried out to determine the acceptability or otherwise of any risks that are identified. This is done by carrying out an assessment of the risks associated with the relevant individual components of the biocidal product taking into account any cumulative and synergistic effects. Scientific definitions and methodologies for the assessment of cumulative or synergistic effects will be based on the technical guidance notes provided by the Commission as foreseen in Article 23.
Amendment 353 #
Council position
Annex VI – Assessment – point 15
Annex VI – Assessment – point 15
15. In carrying out the assessment, the possibility of cumulative or synergistic effects shall also be taken into account. Scientific definitions and methodologies for the assessment of cumulative or synergistic effects will be based on the technical guidance notes provided by the Commission as foreseen in Article 23.
Amendment 355 #
Council position
Annex VI – Assessment – point 52
Annex VI – Assessment – point 52
52. In each of the areas where risk assessments have been carried out, the evaluating body shall combine the results for the active substance together with the results for any substance of concern to produce an overall assessment for the biocidal product itself. This shall also take account of any cumulative or synergistic effects. Scientific definitions and methodologies for the assessment of cumulative or synergistic effects will be based on the technical guidance notes provided by the Commission as foreseen in Article 23.
Amendment 356 #
Council position
Annex VI – Conclusions – point 62
Annex VI – Conclusions – point 62
62. If for non-professional users the wearing of personal protective equipment would be the only possible method for reducing exposure to an acceptable level for this population as a result of the biocidal product risk assessment, the product shall not normally be considered as complying with criterion (iii) under point (b) of Article 18(1) for this population.
Amendment 359 #
Proposal for a regulation
Article 41 – paragraph 2 a (new)
Article 41 – paragraph 2 a (new)
2 a. An amendment to an existing authorisation should fall under one of the following categories of changes; a) 'Administrative change' b) 'Minor change' c) 'Major change' as defined in Article 3 (a) new, (b) new and (c) new.
Amendment 362 #
Proposal for a regulation
Article 42 – paragraph 1 a (new)
Article 42 – paragraph 1 a (new)
The criteria and the procedures referred to in paragraph 1 of this Article shall be based on, but not limited to, the following principles: (a) a simplified notification procedure shall be applied for administrative changes to the authorisation; (b) a reduced evaluation period shall be established for minor changes to the authorisation; (c) in the case of major changes the evaluation period should be proportionate to the extent of the proposed change.
Amendment 377 #
Proposal for a regulation
Article 45 – paragraph 1 – subparagraph 1
Article 45 – paragraph 1 – subparagraph 1
1. By way of derogation from Articles 15 and 16, a competent authority may authorise for a period not exceeding nine months, the placing on the market of a biocidal product not complying with the provisions of this Regulation for a limited and controlled use if such a measure is necessary because of a danger to public health or the environment which cannot be contained by other means that pose a lower risk.
Amendment 381 #
Proposal for a regulation
Article 46 – paragraph 1 – subparagraph 2
Article 46 – paragraph 1 – subparagraph 2
In the case of scientific research and development, including product and process-oriented research and development, the person who intends to carry out the experiment or the test shall notify the competent authority prior to the start. The person shall draw up and maintain written records detailing the identity of the biocidal product or active substance, labelling data, and quantities supplied and the names and addresses of those persons receiving the biocidal product or active substance, and shall compile a dossier containing all available data on possible effects on human or animal health or impact on the environment. The persons concerned shall, if requested, make this information available to the competent authority.
Amendment 384 #
Proposal for a regulation
Article 46 – paragraph 1 – subparagraph 3
Article 46 – paragraph 1 – subparagraph 3
Amendment 388 #
Proposal for a regulation
Article 46 – paragraph 2
Article 46 – paragraph 2
2. An unauthorised biocidal product or an active substance for exclusive use in a biocidal product shall not be placed on the market for the purpose of any experiment or test which may involve, or result in, release of the biocidal product into the environment unless the competent authority has assessed the data submitted by the person interested in the placing of such product on the market and issued a national authorisatpositive opinion for this purpose which limits the quantities to be used and the areas to be treated and which may impose further conditions. The competent authority shall without delay inform the Commission and other competent authorities about the issuedmay impose further conditions. In the absence of an opinion from the competent authority within 30 days of the notification of the information required in paragraph 1, the biocidal product or active substance may be placed on the market for the purpose of the naotional authorisationfied experiment or test.
Amendment 389 #
Proposal for a regulation
Article 46 – paragraph 3 – subparagraph 1
Article 46 – paragraph 3 – subparagraph 1
3. Where any experiment or test takes place in a Member State other than the Member State where placing on the market of the biocidal product occurs, the applicant shall obtain experiment or test authorisation fromnotify the competent authority of the Member State in the territory of which the experiments or tests are to be conducted. The applicant shall draw up and maintain written records detailing the identity of the biocidal product or active substance, labelling data and quantities supplied, and shall compile a dossier containing all available data on possible effects on human or animal health or impact on the environment. The applicant shall, if requested, make this information available to the competent authority.
Amendment 395 #
Proposal for a regulation
Article 47 – paragraph 1
Article 47 – paragraph 1
1. Treated materials or articles that incorporate one or more biocidal products shall not be placed on the market unless the biocidal product(s) used for treating the materials or the articles are authorised for this use in the Community or in at least one Member State, or the biocidal product is present in those articles in transit in a concentration of less than 0.01% weight by weight.
Amendment 397 #
Proposal for a regulation
Article 47 – paragraph 2 – point a
Article 47 – paragraph 2 – point a
a) the name, using wherever possible common nomenclature (e.g. INCI) of all active substances that were used to treat the article or materials or that were incorporated in the articles or materials, where relevant and for all active substances which are intended to be released under normal or foreseeable conditions of use from the treated article or material, unless labelling requirements or alternative means to meet information requirements already exist under sector- specific legislation;
Amendment 403 #
Proposal for a regulation
Article 47 – paragraph 2 – point b
Article 47 – paragraph 2 – point b
b) where relevant, the biocidal property attributed to treated articles or materials;
Amendment 406 #
Proposal for a regulation
Article 47 – paragraph 2 – point d
Article 47 – paragraph 2 – point d
d) only for treated articles and where relevant, any hazard statement or precautionary statement set out in the authorisation for the biocidal product .
Amendment 447 #
Proposal for a regulation
Article 65 – paragraph 1 – subparagraph 1 – point f a (new)
Article 65 – paragraph 1 – subparagraph 1 – point f a (new)
Amendment 476 #
Proposal for a regulation
Article 82
Article 82
Amendment 479 #
Proposal for a regulation
Annex II – heading 1 – point 1
Annex II – heading 1 – point 1
1. Dossiers on active substances shall contain the information needed to establish, where relevant, that exposure is below the Threshold of Toxicological Concern (TTC), or where relevant, to establish the Acceptable Daily Intake (ADI), Acceptable Operator Exposure Level (AOEL), Predicted Environmental Concentration (PEC) and Predicted No-Effect Concentration (PNEC).
Amendment 481 #
Proposal for a regulation
Annex II – heading 1 – point 4
Annex II – heading 1 – point 4
4. Tests submitted for the purpose of authorisation shall be conducted according to the methods described in Council Regulation (EC) No 440/2008. However, if a method is inappropriate or not described, other methods shall be used which are, whenever possible, internationally recognised scientifically appropriate and must be justified in the application.
Amendment 484 #
Proposal for a regulation
Annex II – title 1 - paragraph 4
Annex II – title 1 - paragraph 4
Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be avoided. Prior to testing, further guidance on intelligent testing strategies should be consultedsought from experts in alternatives to animal experimentation in addition to this Annex.
Amendment 485 #
Proposal for a regulation
Annex II - title 1 - table - section 6.1.1
Annex II - title 1 - table - section 6.1.1
Amendment 486 #
Proposal for a regulation
Annex II - title 1 - table - section 6.2.1
Annex II - title 1 - table - section 6.2.1
Amendment 487 #
Proposal for a regulation
Annex II - title 1 - table - section 6.3
Annex II - title 1 - table - section 6.3
6.3. The assessment of this endpoint shall comprise the following consecutive steps: (1) an assessment of the available human, animal and alternative data, (2) In vivo testing. Step 2 does not need to be conducted if: – the available information indicates that the substance should be classified for skin sensitisation or corrosivity; or – the substance is a strong acid (pH < 2,0) or base (pH > 11,5); or – the substance is flammable in air at room temperature. The reduced Murine Local Lymph Node Assay (rLLNA) is the first-choice method for in vivo testing as a screening test to distinguish between sensitisers and non- sensitisers. The full LLNA should be performed when it is known that an assessment of sensitisation potency is required. Only in exceptional circumstances should another test be used. Justification for the use of another test shall be provided.
Amendment 488 #
Proposal for a regulation
Annex II - title 1 - table - section 6.4
Annex II - title 1 - table - section 6.4
6.4. Appropriate in vivo mutagenicity studies shall be considered in case of a positive result in any of the genotoxicity studies in Tier 1. For new substances, it is advisable to assess the parameters of an in-vivo micronucleus test as part of a 28- or 90- day repeated dose toxicity study.
Amendment 489 #
Proposal for a regulation
Annex II - title 1 - table - section 6.4.1
Annex II - title 1 - table - section 6.4.1
6.4.1 Further mutagenicity studies shall be considered in case of a positive result. Such a study does not need to be conducted in the case of antimicrobial substances or formulations.
Amendment 490 #
Proposal for a regulation
Annex II - title 1 - table - section 6.4.3
Annex II - title 1 - table - section 6.4.3
6.4.3. The study does not usually need to be conducted if adequate data from a reliable in vivo mammalian gene mutation test are available elsewhere.
Amendment 491 #
Proposal for a regulation
Annex II - title 1 - table - section 6.4.4 - subparagraph 1
Annex II - title 1 - table - section 6.4.4 - subparagraph 1
6.4.4. If there is a positive result in any of the in vitro genotoxicity studies in Tier I and there are no results available from an in vivo study already, an appropriate in vivo somatic cell genotoxicity study shall be proposed by the applicant. For new substances, it should be possible to assess the parameters of an in-vivo micronucleus test as part of a 28- or 90-day repeated dose toxicity study.
Amendment 492 #
Proposal for a regulation
Annex II - title 1 - table - section 6.5
Annex II - title 1 - table - section 6.5
6.5. The study/ies do(es) not generally need to be conducted if: - the substance is classified as corrosive to the skin. In addition to the oral route (6.5.1.), for substances other than gases, the information mentioned under 5.6.2. to 6.5.3. shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only route need be provided.
Amendment 493 #
Proposal for a regulation
Annex II - title 1 - table - section 6.5.1
Annex II - title 1 - table - section 6.5.1
6.5.1. The study need not be conducted if a study on acute toxicity by the inhalation route (6.5.2) is available. The Acute Toxic Class Method is the first- choice method for in-vivo testing. Only in exceptional circumstances should another test be used, in which case a justification shall be provided.
Amendment 494 #
Proposal for a regulation
Annex II - title 1 - table - section 6.5.2
Annex II - title 1 - table - section 6.5.2
6.5.2. Testing by the inhalation route is appropriate if exposure of humans via inhalation is likelyonly if this constitutes the primary route of human exposure taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. The Acute Toxic Class Method is the first-choice method for in-vivo testing. Only in exceptional circumstances should the classic “lethal concentration” (LC50) test be used. Justification for the use of another test shall be provided.
Amendment 495 #
Proposal for a regulation
Annex II - title 1 - table - section 6.5.3
Annex II - title 1 - table - section 6.5.3
Amendment 502 #
Proposal for a regulation
Annex II - title 1 - table - section 6.7.2
Annex II - title 1 - table - section 6.7.2
6.7.2. The study shall be initially 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 only, ideally in combination with an enhanced one-generation reproductive toxicity study (Tier II, section 6.7.3).
Amendment 503 #
Proposal for a regulation
Annex II - title 1 - table - section 6.7.3
Annex II - title 1 - table - section 6.7.3
6.7.3. TwoEnhanced one-generation reproductive toxicity study, 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 Tier 1 requirements.
Amendment 504 #
Proposal for a regulation
Annex II - title 1 - table - section 6.7.3
Annex II - title 1 - table - section 6.7.3
Amendment 505 #
Proposal for a regulation
Annex II - title 1 - table - section 6.8.1
Annex II - title 1 - table - section 6.8.1
6.8.1. DIn-vitro dermal absorption study
Amendment 506 #
Proposal for a regulation
Annex II - title 1 - table - section 6.9
Annex II - title 1 - table - section 6.9
6.9. A carcinogenicity study may be proposed by the applicant or may be required if: - the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure; and - the substance is classified as mutagen category 2 or there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre- neoplastic lesions. If the substance is classified as mutagen category 1A or 1B, the default presumption would be that a genotoxic mechanism for carcinogenicity is likely. In these cases, a carcinogenicity test will normally not be required. If long-term toxicity data are also required and not already available, carcinogenicity and long-term repeated dose studies should be carried out using the OECD TG 453 combination study protocol.
Amendment 507 #
Proposal for a regulation
Annex II - title 1 - table- section 7.1
Annex II - title 1 - table- section 7.1
7.1. Requirements for aquatic toxicity testing on vertebrate animals may be waived if the use profile for a substance does not indicate significant potential for exposure to the aquatic environment. Long-term toxicity testing shall be proposed by the applicant if the assessment performed under Tier I indicates the need to investigate further the effects on aquatic organisms. The choice of the appropriate test(s) depends on the results of the assessment performed under Tier I.
Amendment 508 #
Proposal for a regulation
Annex II - title 1 - table - section 7.1.3
Annex II - title 1 - table - section 7.1.3
7.1.3. Short-term toxicity testing on fish: The applicant may consider long-term toxicity testing instead of short-termthreshold approach.
Amendment 509 #
Proposal for a regulation
Annex II - title 1 - table - section 7.1.6
Annex II - title 1 - table - section 7.1.6
7.1.6. Long-term toxicity testing on fish, (unless already provided as part of Tier I requirements) if indicated by substance use profile and/or physical-chemical properties The information shall be provided for one of the sections 7.1.6.1, 7.1.6.2 or 7.1.6.3.
Amendment 510 #
Proposal for a regulation
Annex II - title 1 - table - section 7.4.1
Annex II - title 1 - table - section 7.4.1
Amendment 513 #
Proposal for a regulation
Annex II - title 1 - table - section 11.1.1
Annex II - title 1 - table - section 11.1.1
Amendment 514 #
Proposal for a regulation
Annex II - title 1 - table - section 11.1.2
Annex II - title 1 - table - section 11.1.2
11.1.2. Short-term toxicity - eight-day dietary study in at least one species (other than chickens)
Amendment 516 #
Proposal for a regulation
Annex II - title 1 - table - section 11.2
Annex II - title 1 - table - section 11.2
Amendment 542 #
Proposal for a regulation
Annex III- title 1 - section 6.4
Annex III- title 1 - section 6.4
(6.4) Information on in-vitro dermal absorption
Amendment 544 #
Proposal for a regulation
Annex III - title 1 - section 9.3.1.1
Annex III - title 1 - section 9.3.1.1
Amendment 551 #
Proposal for a regulation
Annex III - title 2 - section 9.1
Annex III - title 2 - section 9.1
Amendment 552 #
Proposal for a regulation
Annex III - title 2 - section 9.2
Annex III - title 2 - section 9.2
Amendment 553 #
Proposal for a regulation
Annex III - title 2 - section 9.7.2
Annex III - title 2 - section 9.7.2