LegalizeRegulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC
The dossier submitted pursuant to Article 7(1) shall be sufficient to permit, where relevant, an estimate of the fate and distribution of the active substance in the environment, and its impact on non-target species.
An active substance alone or associated with a safener or synergist shall only be approved where it has been established for one or more representative uses that the plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use is sufficiently effective. This requirement shall be evaluated in accordance with the uniform principles for evaluation and authorisation of plant protection products referred to in Article 29(6).
Where applicable the documentation submitted shall be sufficient to permit the establishment of the toxicological, ecotoxicological or environmental relevance of metabolites.
3.4.1. For chemical active substances, safeners and synergists, the specification shall define the minimum degree of purity, the identity and maximum content of impurities and, where relevant, of isomers/diastereo-isomers and additives, and the content of impurities of toxicological, ecotoxicological or environmental concern within acceptable limits.
3.4.2. For chemical active substances, safeners and synergists, the specification shall be in compliance with the relevant Food and Agriculture Organisation specification as appropriate, where such specification exists. However, where necessary for reasons of protection of human or animal health or the environment, stricter specifications may be adopted.
3.4.3. Active substances that are micro-organisms shall be deposited at an internationally recognised culture collection and shall have an accession number. The species’ name of the micro-organisms shall be identified unequivocally, based on the latest scientific information, and the micro-organisms shall be named at the strain level, including any other designation which may be relevant (e.g. isolate level, if relevant for viruses). It shall be indicated whether or not the micro-organisms are wild types, spontaneous or induced mutants, or genetically modified organisms.
3.4.4. For active substances that are micro-organisms, the specification shall define the minimum and maximum content of the micro-organism, the identity and content of relevant contaminating micro-organisms, metabolites of concern and impurities of toxicological, ecotoxicological or environmental concern within acceptable limits.
3.5.1. The methods of analysis of chemical active substances, safeners or synergists as manufactured and of determination of impurities of toxicological, ecotoxicological or environmental concern or which are present in quantities greater than 1 g/kg in the active substance, safener or synergist as manufactured, shall have been validated and shown to be sufficiently specific, correctly calibrated, accurate and precise.
3.5.2. The methods of residue analysis for chemical active substances and relevant metabolites in plant, animal and environmental matrices and drinking water, as appropriate, shall have been validated and shown to be sufficiently sensitive with respect to the levels of concern.
3.5.3. The evaluation shall have been carried out in accordance with the uniform principles for evaluation and authorisation of plant protection products referred to in Article 29(6).
3.5.4. For active substances that are micro-organisms, the methods of analysis to identify and quantify them, and relevant contaminating micro-organisms, shall have been validated and shown to be sufficiently specific, correctly calibrated, accurate and precise.
3.5.5. For active substances that are micro-organisms, the methods of analysis of metabolites of concern and relevant impurities shall have been validated and shown to be sufficiently specific, correctly calibrated, accurate and precise.
3.6.1.Where relevant, an ADI, AOEL and ARfD shall be established. When establishing such values an appropriate safety margin of at least 100 shall be ensured taking into account the type and severity of effects and the vulnerability of specific groups of the population. When the critical effect is judged of particular significance, such as developmental neurotoxic or immunotoxic effects, an increased margin of safety shall be considered, and applied if necessary.
3.6.2.An active substance, safener or synergist shall only be approved if, on the basis of assessment of higher tier genotoxicity testing carried out in accordance with the data requirements for the active substances, safeners or synergists and other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as mutagen category 1A or 1B.
3.6.3.An active substance, safener or synergist shall only be approved, if, on the basis of assessment of carcinogenicity testing carried out in accordance with the data requirements for the active substances, safener or synergist and other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogen category 1A or 1B, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with Article 18(1)(b) of Regulation (EC) No 396/2005.
3.6.4.An active substance, safener or synergist shall only be approved if, on the basis of assessment of reproductive toxicity testing carried out in accordance with the data requirements for the active substances, safeners or synergists and other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 1A or 1B, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005.
3.6.5.An active substance, safener or synergist shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not considered to have endocrine disrupting properties that may cause adverse effect in humans, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005.
By 14 December 2013, the Commission shall present to the Standing Committee on the Food Chain and Animal Health a draft of the measures concerning specific scientific criteria for the determination of endocrine disrupting properties to be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).
Pending the adoption of these criteria, substances that are or have to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogenic category 2 and toxic for reproduction category 2, shall be considered to have endocrine disrupting properties.
In addition, substances such as those that are or have to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 2 and which have toxic effects on the endocrine organs, may be considered to have such endocrine disrupting properties.
From 10 November 2018 , an active substance, safener or synergist shall be considered as having endocrine disrupting properties that may cause adverse effect in humans if, based on points (1) to (4) of the sixth paragraph, it is a substance that meets all of the following criteria, unless there is evidence demonstrating that the adverse effects identified are not relevant to humans:
(1) it shows an adverse effect in an intact organism or its progeny, which is a change in the morphology, physiology, growth, development, reproduction or life span of an organism, system or (sub)population that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress or an increase in susceptibility to other influences;
(2) it has an endocrine mode of action, i.e. it alters the function(s) of the endocrine system;
(3) the adverse effect is a consequence of the endocrine mode of action.
The identification of an active substance, safener or synergist as having endocrine disrupting properties that may cause adverse effect in humans in accordance with the fifth paragraph shall be based on all of the following points:
(1) all available relevant scientific data (in vivo studies or adequately validated alternative test systems predictive of adverse effects in humans or animals; as well as in vivo, in vitro, or, if applicable, in silico studies informing about endocrine modes of action): (a) scientific data generated in accordance with internationally agreed study protocols, in particular those listed in the Commission Communications in the framework of setting out the data requirements for active substances and plant protection products, in accordance with this Regulation; (b) other scientific data selected applying a systematic review methodology, in particular following guidance on literature data which is listed in the Commission Communications in the framework of setting out the data requirements for active substances and plant protection products, in accordance with this Regulation;
(2) an assessment of the available relevant scientific data based on a weight of evidence approach in order to establish whether the criteria set out in the fifth paragraph are fulfilled; in applying the weight of evidence determination, the assessment of the scientific evidence shall, in particular, consider all of the following factors: (a) both positive and negative results; (b) the relevance of the study designs, for the assessment of adverse effects and of the endocrine mode of action; (c) the quality and consistency of the data, considering the pattern and coherence of the results within and between studies of a similar design and across different species; (d) the route of exposure, toxicokinetic and metabolism studies; (e) the concept of the limit dose, and international guidelines on maximum recommended doses and for assessing confounding effects of excessive toxicity;
(3) using a weight of evidence approach, the link between the adverse effect(s) and the endocrine mode of action shall be established based on biological plausibility, which shall be determined in the light of current scientific knowledge and under consideration of internationally agreed guidelines;
(4) adverse effects that are non-specific secondary consequences of other toxic effects shall not be considered for the identification of the substance as endocrine disruptor.
3.6.6.Active substances that are micro-organisms shall only be approved if, on the basis of the assessment carried out on the information provided in accordance with the data requirements, it is concluded that the strain of the micro-organism is not pathogenic to humans.
In addition:
(a) viruses shall only be approved if, on the basis of the assessment carried out on the information provided in accordance with the data requirements, it is concluded that the isolate of the virus is not infective to humans;
(b) strains of bacteria shall only be approved if, on the basis of the assessment carried out on the information provided in accordance with the data requirements, it is concluded that they do not have any known, functional and transferable gene coding for resistance to relevant antimicrobial agents as defined in accordance with the data requirements.
3.7.1. An active substance, safener or synergist shall only be approved where it is not considered to be a persistent organic pollutant (POP). A substance that fulfils all three of the criteria of the points below is a POP. 3.7.1.1. Persistence An active substance, safener or synergist fulfils the persistence criterion where there is evidence that the time it takes for a degradation of 50 % (DT50) in water is greater than 2 months, or that its DT50 in soil is greater than 6 months, or that its DT50 in sediment is greater than 6 months. 3.7.1.2. Bioaccumulation An active substance, safener or synergist fulfils the bioaccumulation criterion where there is: 3.7.1.3. Potential for long-range environmental transport: An active substance, safener or synergist fulfils the potential for long-range environmental transport criterion where:
3.7.2. An active substance, safener or synergist shall only be approved if it is not considered to be a persistent, bioaccumulative and toxic (PBT) substance. A substance that fulfils all three of the criteria of the points below is a PBT substance. 3.7.2.1. Persistence An active substance, safener or synergist fulfils the persistence criterion where: Assessment of persistency in the environment shall be based on available half-life data collected under appropriate conditions, which shall be described by the applicant. 3.7.2.2. Bioaccumulation An active substance, safener or synergist fulfils the bioaccumulation criterion where the bioconcentration factor is higher than 2 000 . Assessment of bioaccumulation shall be based on measured data on bioconcentration in aquatic species. Data from both freshwater and marine water species can be used. 3.7.2.3. Toxicity An active substance, safener or synergist fulfils the toxicity criterion where:
3.7.3. An active substance, safener or synergist shall only be approved if it is not considered to be a very persistent and very bioaccumulative substance (vPvB). A substance that fulfils both of the criteria of the points below is a vPvB substance. 3.7.3.1. Persistence An active substance, safener or synergist fulfils the ‘very persistent’ criterion where: 3.7.3.2. Bioaccumulation An active substance, safener or synergist fulfils the ‘very bioaccumulative’ criterion where the bioconcentration factor is greater than 5 000 .
3.8.1.An active substance, safener or synergist shall only be approved if the risk assessment demonstrates risks to be acceptable in accordance with the criteria laid down in the uniform principles for evaluation and authorisation of plant protection products referred to in Article 29(6) under realistic proposed conditions of use of a plant protection product containing the active substance, safener or synergist. The assessment must take into account the severity of effects, the uncertainty of the data, and the number of organism groups which the active substance, safener or synergist is expected to affect adversely by the intended use.
3.8.2.An active substance, safener or synergist shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines, it is not considered to have endocrine disrupting properties that may cause adverse effects on non-target organisms unless the exposure of non-target organisms to that active substance in a plant protection product under realistic proposed conditions of use is negligible.
From 10 November 2018 , an active substance, safener or synergist shall be considered as having endocrine disrupting properties that may cause adverse effects on non-target organisms if, based on points (1) to (4) of the third paragraph, it is a substance that meets all of the following criteria, unless there is evidence demonstrating that the adverse effects identified are not relevant at the (sub)population level for non-target organisms:
(1) it shows an adverse effect in non-target organisms, which is a change in the morphology, physiology, growth, development, reproduction or life span of an organism, system or (sub)population that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress or an increase in susceptibility to other influences;
(2) it has an endocrine mode of action, i.e. it alters the function(s) of the endocrine system;
(3) the adverse effect is a consequence of the endocrine mode of action.
The identification of an active substance, safener or synergist as having endocrine disrupting properties that may cause adverse effects on non-target organisms in accordance with the second paragraph shall be based on all of the following points:
(1) all available relevant scientific data (in vivo studies or adequately validated alternative test systems predictive of adverse effects in humans or animals; as well as in vivo, in vitro, or, if applicable, in silico studies informing about endocrine modes of action): (a) scientific data generated in accordance with internationally agreed study protocols, in particular, those listed in the Commission Communications in the framework of setting out the data requirements for active substances and plant protection products, in accordance with this Regulation; (b) other scientific data selected applying a systematic review methodology, in particular following guidance on literature data listed in the Commission Communications in the framework of setting out the data requirements for active substances and plant protection products, in accordance with this Regulation;
(2) an assessment of the available relevant scientific data based on a weight of evidence approach in order to establish whether the criteria set out in the second paragraph are fulfilled; in applying the weight of evidence determination, the assessment of the scientific evidence shall consider all of the following factors: (a) both positive and negative results, discriminating between taxonomic groups (e.g. mammals, birds, fish, amphibians) where relevant; (b) the relevance of the study design for the assessment of the adverse effects and its relevance at the (sub)population level, and for the assessment of the endocrine mode of action; (c) the adverse effects on reproduction, growth/development, and other relevant adverse effects which are likely to impact on (sub)populations. Adequate, reliable and representative field or monitoring data and/or results from population models shall as well be considered where available; (d) the quality and consistency of the data, considering the pattern and coherence of the results within and between studies of a similar design and across different taxonomic groups; (e) the concept of the limit dose and international guidelines on maximum recommended doses and for assessing confounding effects of excessive toxicity;
(3) using a weight of evidence approach, the link between the adverse effect(s) and the endocrine mode of action shall be established based on biological plausibility, which shall be determined in the light of current scientific knowledge and under consideration of internationally agreed guidelines;
(4) Adverse effects that are non-specific secondary consequences of other toxic effects shall not be considered for the identification of the substance as endocrine disruptor with respect to non-target organisms.
3.8.3.An active substance, safener or synergist shall be approved only if it is established following an appropriate risk assessment on the basis of Community or internationally agreed test guidelines, that the use under the proposed conditions of use of plant protection products containing this active substance, safener or synergist:
— will result in a negligible exposure of honeybees, or
— has no unacceptable acute or chronic effects on colony survival and development, taking into account effects on honeybee larvae and honeybee behaviour.
An active substance, safener or synergist shall only be approved if, where relevant, a residue definition can be established for the purposes of risk assessment and for enforcement purposes.
An active substance shall only be approved where it has been established for one or more representative uses, that consequently after application of the plant protection product consistent with realistic conditions on use, the predicted concentration of the active substance or of metabolites, degradation or reaction products in groundwater complies with the respective criteria of the uniform principles for evaluation and authorisation of plant protection products referred to in Article 29(6).
4. Candidate for substitution
An active substance shall be approved as a candidate for substitution pursuant to Article 24 where any of the following conditions are met:
— its ADI, ARfD or AOEL is significantly lower than those of the majority of the approved active substances within groups of substances/use categories,
— it meets two of the criteria to be considered as a PBT substance,
— there are reasons for concern linked to the nature of the critical effects (such as developmental neurotoxic or immunotoxic effects) which, in combination with the use/exposure patterns, amount to situations of use that could still cause concern, for example, high potential of risk to groundwater; even with very restrictive risk management measures (such as extensive personal protective equipment or very large buffer zones),
— it contains a significant proportion of non-active isomers,
— it is or is to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogen category 1A or 1B, if the substance has not been excluded in accordance with the criteria laid down in point 3.6.3,
— it is or is to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 1A or 1B if the substance has not been excluded in accordance with the criteria laid down in point 3.6.4,
— if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information, reviewed by the Authority, it is considered to have endocrine disrupting properties that may cause adverse effects in humans if the substance has not been excluded in accordance with the criteria laid down in point 3.6.5.
5. Low-risk active substances
5.1.1. An active substance, other than a micro-organism, shall not be considered as being of low-risk where it corresponds to any of the following:
5.1.2. An active substance, other than a micro-organism, shall not be considered as being of low-risk where it is persistent (half-life in soil is more than 60 days) or its bio-concentration factor is higher than 100. However, a naturally occurring active substance which does not correspond to any of points (a) to (d) of point 5.1.1 may be considered as being of low-risk, even if it is persistent (half-life in soil is more than 60 days) or its bio-concentration factor is higher than 100.
5.1.3. An active substance, other than a micro-organism, emitted and used by plants, animals and other organisms for communication, shall be considered as being of low- risk where it does not correspond to any of points (a) to (d) of point 5.1.1.
5.2.1. An active substance that is a micro-organism other than a virus may be considered a low-risk active substance unless its susceptibility to at least two classes of antimicrobial agents has not been demonstrated.
5.2.2. An active substance that is a virus may be considered a low-risk active substance unless it is: (a) a baculovirus with demonstrated adverse effects on non-target insects; or (b) a non-virulent variant of a plant pathogen with demonstrated adverse effects on non-target plants.
ANNEX III
| No | Name | EC names/Other names | CAS number | EC number | Classification/Other properties |
|---|---|---|---|---|---|
| 1. | 1-Chloro-2,3-epoxypropane | Epichlorohydrin, 2,3-Epoxypropyl chloride | 106-89-8 | 203-439-8 | Carcinogenic cat.1B |
| 2. | 1,2- Dichloroethane | 1,2-Dichloroethane; Ethane, 1,2-dichloro- | 107-06-2 | 203-458-1 | Carcinogenic cat.1B |
| 3. | 2-Ethoxyethanol | 2-Ethoxyethanol; Ethanol, 2-ethoxy- | 110-80-5 | 203-804-1 | Toxic to reproduction cat.1B |
| 4. | 2-Ethoxyethyl acetate | 2-Ethoxyethanol acetate; Ethanol, 2-ethoxy-, 1-acetate | 111-15-9 | 203-839-2 | Toxic to reproduction cat.1B |
| 5. | 1-Ethylpyrrolidin-2-one | 1-Ethylpyrrolidin-2-one; N-ethyl-2-pyrrolidone | 2687-91-4 | 220-250-6 | Toxic to reproduction cat.1B |
| 6. | 2-Methoxyethanol | 2-Methoxyethanol; Ethanol, 2-methoxy- | 109-86-4 | 203-713-7 | Toxic to reproduction cat.1B |
| 7. | 2-Methoxyethyl acetate | 2-Methoxyethyl acetate; Ethanol, 2-methoxy-, 1-acetate; 2-Methoxyethanol acetate | 110-49-6 | 203-772-9 | Toxic to reproduction cat.1B |
| 8. | 2-Methoxypropanol | 2-Methoxypropanol; 1-Propanol, 2-methoxy- | 1589-47-5 | 216-455-5 | Toxic to reproduction cat.1B |
| 9. | 1-Methylpyrrolidin-2-one | 1-Methyl-2-pyrrolidone; 2-Pyrrolidinone, 1-methyl- | 872-50-4 | 212-828-1 | Toxic to reproduction cat.1B |
| 10. | 2-Nitropropane | 2-Nitropropane; Propane, 2-nitro- | 79-46-9 | 201-209-1 | Carcinogenic cat.1B |
| 11. | Amines, tallow alkyl, ethoxylated | Amines, tallow alkyl, ethoxylated; POE-tallowamine | 61791-26-2 | Concerns or data gaps related to potential effects on human health or the environment | |
| 12. | Amines, tallow alkyl, ethoxylated propoxylated | Amines, tallow alkyl, ethoxylated propoxylated; POEP-tallowamine | 68213-26-3 | Concerns or data gaps related to potential effects on human health or the environment | |
| 13. | Asbestos fibres | Actinolite asbestos; Asbestos, actinolyte | 77536-66-4 | Carcinogenic cat.1A | |
| 14. | Amosite asbestos; Asbestos, amosite | 12172-73-5 | Carcinogenic cat.1A | ||
| 15. | Anthophyllite asbestos; Asbestos, anthophyllite | 77536-67-5 | Carcinogenic cat.1A | ||
| 16. | Chrysotile asbestos; Asbestol, chrysotile | 12001-29-5 | Carcinogenic cat.1A | ||
| 17. | Crocidolite asbestos; Asbestos, crocidolite | 12001-28-4 | Carcinogenic cat.1A | ||
| 18. | Tremolite asbestos; Asbestos, tremolite | 77536-68-6 | Carcinogenic cat.1A | ||
| 19. | Benzene | Benzene | 71-43-2 | 200-753-7 | Carcinogenic cat.1A/ Mutagenic cat.1B |
| 20. | Benzo[def]chrysene; (2) Benzo[pqr]tetraphene | Benzo[def]chrysene; Benzo[a]pyrene | 50-32-8 | 200-028-5 | Carcinogenic cat.1B/Mutagenic cat.1B/ Toxic to reproduction cat.1B |
| 21. | Bis(2-methylpropyl) benzene-1,2-dicarboxylate | Diisobutyl phthalate | 84-69-5 | 201-553-2 | Endocrine disrupting properties (REACH Article 57(f) – Human Health) Toxic to reproduction cat.1B |
| 22. | Boric acid | Boric acid | 10043-35-3 11113-50-1 | 233-139-2 234-343-4 | Toxic to reproduction cat.1B |
| 23. | Disodium octaborate | Disodium octaborate; Disodium octaborate anhydrous | 12008-41-2 | 234-541-0 | Toxic to reproduction cat.1B |
| 24. | Disodium octaborate, tetrahydrate | Boric acid, disodium salt, tetrahydrate; | 12280-03-4 | 234-541-0 | Toxic to reproduction cat.1B |
| 25. | Disodium tetraborate, anhydrous | Disodium tetraborate, anhydrous; Boron sodium oxide | 1330-43-4 | 215-540-4 | Toxic to reproduction cat.1B |
| 26. | Disodium tetraborate, decahydrate | Borax | 1303-96-4 | 215-540-4 | Toxic to reproduction cat.1B |
| 27. | Disodium tetraborate, pentahydrate | Boron sodium oxide, hydrated | 12179-04-3 | 215-540-4 | Toxic to reproduction cat.1B |
| 28. | Orthoboric acid, sodium salt | Orthoboric acid, sodium salt; Boric acid, sodium salt | 13840-56-7 | 237-560-2 | Toxic to reproduction cat.1B |
| 29. | Tetraboron disodium heptaoxide, hydrate | Tetraboron disodium heptaoxide, hydrate; Boron sodium oxide, hydrate | 12267-73-1 | 235-541-3 | Toxic to reproduction cat.1B |
| 30. | Buta-1,3-diene | Buta-1,3-diene; 1,3-Butadiene | 106-99-0 | 203-450-8 | Carcinogenic cat.1A/ Mutagenic cat.1B |
| 31. | Butane containing ≥ 0,1 % butadiene (EC No 203-450-8) | Butane | 106-97-8 | 203-448-7 | Carcinogenic cat.1A |
| 32. | Co Poly (bisiminoimidocarbonyl, hexamethylene hydrochloride),(iminoimidocarbonyl, hexamethylene hydrochloride | Guanidine, N,N" ’-1,6-hexanediylbis[N’-cyano-, polymer with 1,6-hexanediamine, hydrochloride Poly[iminocarbonimidoyliminocarbonimidoylimino-1,6-hexanediyl], hydrochloride Cyanamide, N-cyano-, compd. with 1,6-hexanediamine (2:1), polymer with 1,6-hexanediamine hydrochloride (1:2); PHMB | 27083-27-8 and 32289-58-0 and 1802181-67-4 | Not approved for use in biocidal products for product-type 6 (in-can preservatives). | |
| 33. | Dibutyl phthalate | n-Butyl phthalate; Dibutyl benzene-1,2-dicarboxylate | 84-74-2 | 201-557-4 | Endocrine disrupting properties (REACH Article 57(f) – Human Health) Toxic to reproduction cat.1B |
| 34. | Distillates (petroleum), hydrotreated heavy naphthenic with a content of ≥ 3,0 % DMSO-extract (measured by IP 346) | 64742-52-5 | 265-155-0 | Carcinogenic cat.1B | |
| 35. | Distillates (petroleum), hydrotreated heavy paraffinic with a content of ≥ 3,0 % DMSO-extract (measured by IP 346) | 64742-54-7 | 265-157-1 | Carcinogenic cat.1B | |
| 36. | Distillates (petroleum), hydrotreated light naphthenic with a content of ≥ 3,0 % DMSO-extract (measured by IP 346) | 64742-53-6 | 265-156-6 | Carcinogenic cat.1B | |
| 37. | Distillates (petroleum), hydrotreated light paraffinic with a content of ≥ 3,0 % DMSO-extract (measured by IP 346) | 64742-55-8 | 265-158-7 | Carcinogenic cat.1B | |
| 38. | Distillates (petroleum), solvent-dewaxed heavy paraffinic with a content of ≥ 3,0 % DMSO-extract (measured by IP 346) | 64742-65-0 | 265-169-7 | Carcinogenic cat.1B | |
| 39. | Distillates (petroleum), solvent-refined heavy paraffinic with a content of ≥ 3,0 % DMSO-extract (measured by IP 346) | 64741-88-4 | 265-090-8 | Carcinogenic cat.1B | |
| 40. | Distillates (petroleum), solvent-refined light paraffinic with a content of ≥ 3,0 % DMSO-extract (measured by IP 346) | 64741-89-5 | 265-091-3 | Carcinogenic cat.1B | |
| 41. | Ethylene oxide | Ethylene oxide; Oxyrane; Epoxyethane | 75-21-8 | 200-849-9 | Carcinogenic cat.1B/ Mutagenic cat. 1B |
| 42. | Formaldehyde | Formaldehyde; Formalin; Methanal;,Formol | 50-00-0 | 200-001-8 | Carcinogenic cat.1B |
| 43. | Formamide | Formamide; Methanamide | 75-12-7 | 200-842-0 | Toxic to reproduction cat.1B |
| 44. | Isobutane (containing ≥ 0,1 % butadiene (EC No 203-450-8)) | Isobutane; Propane, 2-methyl- | 75-28-5 | 200-857-2 | Carcinogenic cat.1A/ Mutagenic cat. 1B |
| 45. | Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, high-viscosity with a content of ≥ 3,0 % DMSO-extract (measured by IP 346) | 72623-85-9 | 276-736-3 | Carcinogenic cat.1B | |
| 46. | Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based with a content of ≥ 3,0 % DMSO-extract (measured by IP 346) | 72623-86-0 | 276-737-9 | Carcinogenic cat.1B | |
| 47. | Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based with a content of ≥ 3,0 % DMSO-extract (measured by IP 346) | 72623-87-1 | 276-738-4 | Carcinogenic cat.1B | |
| 48. | Lubricating oils (petroleum), C17-32, solvent-extd., dewaxed, hydrogenated with a content of ≥ 3,0 % DMSO-extract (measured by IP 346) | 101316-70-5 | 309-875-6 | Carcinogenic cat.1B | |
| 49. | Naphtha (petroleum), heavy alkylate predominantly branched chain C9-C12 with a content of ≥ 0,1 % benzene (EC No 200-753-7) | 64741-65-7 | 265-067-2 | Carcinogenic cat.1B/ Mutagenic cat.1B | |
| 50. | Naphtha (petroleum), hydrodesulfurized heavy predominantly C7-C12 with a content of ≥ 0,1 % benzene (EC No 200-753-7) | 64742-82-1 | 265-185-4 | Carcinogenic cat.1A/ Mutagenic cat.1B | |
| 51. | Naphtha (petroleum), hydrodesulfurized light, dearomatized predominantly C7 paraffins and cycloparaffins with a content of ≥ 0,1 % benzene (EC No 200-753-7) | 92045-53-9 | 295-434-2 | Carcinogenic cat.1A/ Mutagenic cat.1B | |
| 52. | Naphtha (petroleum), hydrotreated heavy predominantly C6-C13 with a content of ≥ 0,1 % benzene (EC No 200-753-7) | 64742-48-9 | 265-150-3 | Carcinogenic cat.1A/ Mutagenic cat.1B | |
| 53. | Naphtha (petroleum), light aromatic predominantly C8-C10 with a content of ≥ 0,1 % benzene (EC N. 200-753-7) | 64742-95-6 | 265-199-0 | Carcinogenic cat.1A/ Mutagenic cat.1B | |
| 54. | Nitrobenzene | Nitrobenzene; Benzene, nitro- | 98-95-3 | 202-716-0 | Toxic to reproduction cat.1B |
| 55. | N-methylformamide | N-methylformamide; Formamide, N-methyl- | 123-39-7 | 204-624-6 | Toxic to reproduction cat.1B |
| 56. | Nonyl-phenols: Substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in any position to phenol, covering also substances which include any of the individual isomers or a combination thereof. | 4-(3,5-Dimethylheptan-3-yl)phenol Phenol, 4-(1-ethyl-1,3-dimethylpentyl)-; 4-(1-Ethyl-1,3-dimethylpentyl)phenol | 186825-36-5 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 57. | 4-(3,6-Dimethylheptan-3-yl)phenol Phenol, 4-(1-ethyl-1,4-dimethylpentyl)-; 4-(1-Ethyl-1,4-dimethylpentyl)phenol | 142731-63-3 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 58. | 4-(2-Methyloctan-2-yl)phenol p-(1,1-Dimethylheptyl)phenol; Phenol, 4-(1,1-dimethylheptyl)- | 30784-30-6 | 250-339-5 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 59. | 4-(3-Methyloctan-3-yl)phenol Phenol, 4-(1-ethyl-1-methylhexyl)-; 4-(1-Ethyl-1-methylhexyl)phenol; | 52427-13-1 | 257-907-1 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 60. | 4-Nonylphenol p-Nonylphenol; Phenol, 4-nonyl- | 104-40-5 | 203-199-4 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 61. | Isononylphenol | 11066-49-2 | 234-284-4 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 62. | p-Isononylphenol; Phenol, 4-isononyl- | 26543-97-5 | 247-770-6 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 63. | Nonylphenol; Phenol, nonyl- | 25154-52-3 | 246-672-0 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 64. | Phenol, 4-(1-methyloctyl)-; p-(1-Methyloctyl)phenol | 17404-66-9 | 241-427-4 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 65. | Phenol, 4-nonyl-, branched | 84852-15-3 | 284-325-5 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 66. | Phenol, nonyl-, branched | 90481-04-2 | 291-844-0 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 67. | Nonyl-phenols, ethoxylated: Substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in any position to phenol, ethoxylated, covering also substances which include any of the individual isomers or a combination thereof. | Nonylphenol, ethoxylated; Poly(oxy-1,2-ethanediyl), α-(nonylphenyl)-ω-hydroxy- | 500-024-6 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 68. | 4-Nonylphenol, branched, 1 – 2,5 moles ethoxylated Poly(oxy-1,2-ethanediyl), α-(4-nonylphenyl)-ω-hydroxy-, branched | 500-315-8 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 69. | 4-Nonylphenol, 1 – 2,5 moles ethoxylated | 500-045-0 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 70. | 2-(2-{2-[2-(4-Nonylphenoxy)ethoxy]ethoxy}ethoxy)ethan-1-ol 2-[2-[2-[2-(4-Nonylphenoxy)ethoxy]ethoxy]ethoxy]ethanol; Ethanol, 2-[2-[2-[2-(4-nonylphenoxy)ethoxy]ethoxy]ethoxy]- | 7311-27-5 | 230-770-5 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 71. | 2-[2-(4-Nonylphenoxy)ethoxy]ethanol; Ethanol, 2-[2-(4-nonylphenoxy)ethoxy]- | 20427-84-3 | 243-816-4 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 72. | 20-(4-Nonylphenoxy)-3,6,9,12,15,18-hexaoxaicosan-1-ol; 3,6,9,12,15,18-Hexaoxaeicosan-1-ol, 20- (4-nonylphenoxy)- | 27942-27-4 | 248-743-1 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 73. | 2-[2-[2-[2-(4-Nonylphenoxy)ethoxy]ethoxy]ethoxy]ethan-1-ol Ethanol,2-[2-[2-[2-(4-nonylphenoxy)ethoxy]ethoxy]ethoxy]- | 7311-27-5 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 74. | 26-(4-Nonylphenoxy)-3,6,9,12,15,18,21,24-octaoxahexacosan-1-ol 3,6,9,12,15,18,21,24-Octaoxahexacosan-1-ol, 26-(4-nonylphenoxy)- | 14409-72-4 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 75. | 17-(4-Nonylphenoxy)-3,6,9,12,15-pentaoxaheptadecan-1-ol 3,6,9,12,15-Pentaoxaheptadecan-1-ol, 17-(4-nonylphenoxy)- | 34166-38-6 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 76. | Poly(oxy-1,2-ethanediyl), α-(4-nonylphenyl)-ω-hydroxy-, branched | 127087-87-0 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 77. | Poly(oxy-1,2-ethanediyl), α-(4-nonylphenyl)-ω-hydroxy- | 26027-38-3 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 78. | Ethanol, 2-(4-nonylphenoxy) | 104-35-8 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 79. | Isononylphenol, ethoxylated; Poly(oxy-1,2-ethanediyl), α-(isononylphenyl)-ω-hydroxy- | 37205-87-1 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 80. | 2-[2-(4-tert-Nonylphenoxy) ethoxy] ethanol Ethanol, 2-[2-(4-tert-nonylphenoxy)ethoxy]- | 156609-10-8 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 81. | Poly(oxy-1,2-ethanediyl), α-(nonylphenyl)-ω-hydroxy- Nonylphenol, ethoxylated | 9016-45-9 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 82. | Octyl-phenols: Substances with a linear and/or branched alkyl chain with a carbon number of 8 covalently bound in any position to phenol, covering also substances which include any of the individual isomers or a combination thereof. | p-Octylphenol; 4-Octylphenol | 1806-26-4 | 217-302-5 | Endocrine disrupting properties (REACH Article 57(f) – Environment) |
| 83. | 4-(2,4,4-Trimethylpentan-2-yl)phenol; 4-(1,1,3,3-Tetramethylbutyl)phenol; 4-(tert-octyl) Phenol Phenol, 4-(1,1,3,3-tetramethylbutyl)-; 4-tert-Octylphenol | 140-66-9 | 205-426-2 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 84. | Octylphenol; Phenol, octyl- | 67554-50-1 | 266-717-8 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 85. | Phenol, 2-isooctyl- | 86378-08-7 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 86. | Phenol, isooctyl-; Isooctylphenol | 11081-15-5 | 234-304-1 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 87. | Phenol, 2-octyl-; o-Octylphenol | 949-13-3 | 213-437-9 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 88. | Phenol, 2-sec-octyl-; o-sec-Octylphenol | 26401-75-2 | 247-663-4 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 89. | Phenol, 4-isooctyl-; p-Isooctylphenol | 27013-89-4 | 248-164-4 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 90. | Phenol, 4-sec-octyl-; p-sec-Octylphenol | 27214-47-7 | 248-330-6 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 91. | Phenol, sec-octyl-; sec-Octylphenol | 93891-78-2 | 299-461-0 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 92. | Phenol, 4-(1-ethylhexyl)-; p-(1-Ethylhexyl)phenol | 3307-00-4 | 221-989-7 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 93. | Phenol, 2-(1-methylheptyl)-; o-(1Methylheptyl)phenol | 18626-98-7 | 242-459-1 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 94. | Phenol, 2-(1-ethylhexyl)-; o-(1-Ethylhexyl)phenol | 17404-44-3 | 241-426-9 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 95. | Phenol, 2-(1-propylpentyl)-; o-(1-Propylpentyl)phenol | 37631-10-0 | 253-574-1 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 96. | Phenol, 4-(1-propylpentyl)-; p-(1-Propylpentyl)phenol | 3307 - 01-5 | 221-990-2 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 97. | Phenol, 2-(1-methylheptyl)-; o-(1,1,3,3-Tetramethylbutyl)phenol | 3884-95-5 | 223-420-8 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 98. | Phenol, (1,1,3,3-tetramethylbutyl)-; (1,1,3,3-Tetramethylbutyl)phenol | 27193-28-8 | 248-310-7 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 99. | Phenol, (1-methylheptyl)-; (1-Methylheptyl)phenol | 27985-70-2 | 248-759-9 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 100. | Phenol, 4-(2-methylheptyl)- | 898546-19-5 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 101. | Phenol, 2-(2-ethylhexyl)- | 28752-62-7 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 102. | Phenol, 4-(1-methylheptyl)-; p-(1-Methylheptyl)phenol | 1818-08-2 | 217-332-9 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 103. | Phenol, 4-(2-ethylhexyl)- | 69468-20-8 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 104. | Phenol, 4-(5-methylheptyl)- | 1824164-95-5 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 105. | Phenol, 2-(2-methylheptyl)- | 898546-20-8 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 106. | Phenol, 4-(2-propylpentyl)- | 119747-99-8 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 107. | Phenol, 3-octyl- | 20056-69-3 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 108. | Phenol, 2-(1,1-dimethylhexyl)- | 1824575-79-2 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 109. | Phenol, 4-(1,1-dimethylhexyl)- | 30784-29-3 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 110. | Phenol, 4-(5,5-dimethylhexyl)- | 13330-52-4 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 111. | Phenol, 2-(5,5-dimethylhexyl)- | 1822989-97-8 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 112. | Phenol, 3-(1,1-dimethylhexyl)- | 70435-92-6 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 113. | Phenol, 4-(1,4-dimethylhexyl)- | 164219-26-5 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 114. | Octyl-phenols, ethoxylated: Substances with a linear and/or branched alkyl chain with a carbon number of 8 covalently bound in any position to phenol, ethoxylated, covering also substances which include any of the individual isomers or a combination thereof. | Poly(oxy-1,2-ethanediyl), α-[(1,1,3,3- tetramethylbutyl) phenyl]-ω-hydroxy- 2-(2-[4-(1,1,3,3-Tetramethylbutyl)phenoxy]ethoxy)ethanol Polyethylene Glycol Octylphenyl Ether; | 9036-19-5 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 115. | 2-[4-(2,4,4-Trimethylpentan-2-yl)phenoxy]ethanol Poly(oxy-1,2-ethanediyl), α-[4-(1,1,3,3-tetramethylbutyl)phenyl]-ω-hydroxy- Octylphenol ethoxylated | 9002-93-1 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 116. | 20-[4-(1,1,3,3-Tetramethylbutyl)phenoxy]-3,6,9,12,15,18-hexaoxaicosan-1-ol 3,6,9,12,15,18-Hexaoxaeicosan-1-ol, 20-[4-(1,1,3,3-tetramethylbutyl)phenoxy]- | 2497-59-8 | 219-682-8 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 117. | Ethanol, 2-[4-(1,1,3,3-tetramethylbutyl)phenoxy]- | 2315-67-5 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 118. | Ethanol, 2-[2-[4-(1,1,3,3-tetramethylbutyl)phenoxy]ethoxy]- | 2315-61-9 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 119. | 3,6,9,12,15,18,21,24-Octaoxahexacosan-1-ol, 26-(4-octylphenoxy)-; | 42173-90-0 | 255-695-5 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 120. | Poly(oxy-1,2-ethanediyl), α-(octylphenyl)-ω-hydroxy-, branched | 68987-90-6 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 121. | Poly(oxy-1,2-ethanediyl), α-[4-(6-methylheptyl)phenyl]-ω-hydroxy- | 59379-12-3 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 122. | Ethanol, 2-(4-octylphenoxy)-; 2-(p-Octylphenoxy)ethanol | 51437-89-9 | 257-203-4 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 123. | Poly(oxy-1,2-ethanediyl), α-(4-octylphenyl)-ω-hydroxy- | 26636-32-8 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 124. | Poly(oxy-1,2-ethanediyl), α-[4-(1-methylheptyl)phenyl]-ω-hydroxy- | 73935-42-9 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 125. | 3,6,9,12,15,18-Hexaoxaeicosan-1-ol, 20-(4-octylphenoxy)-; 20-(4-Octylphenoxy)-3,6,9,12,15,18-hexaoxaicosan-1-ol | 32742-88-4 | 251-190-9 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | |
| 126. | Ethanol, 2-[2-[2-[2-(4-octylphenoxy)ethoxy]ethoxy]ethoxy]-; 2-(p-Octylphenoxy)ethanol | 51437-92-4 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 127. | Ethanol, 2-[2-(4-octylphenoxy)ethoxy]- | 51437-90-2 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 128. | 3,6,9,12,15-Pentaoxaheptadecan-1-ol, 17-(4-octylphenoxy)- | 51437-94-6 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 129. | Poly(oxy-1,2-ethanediyl), α-(isooctylphenyl)-ω-hydroxy- | 9004-87-9 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 130. | 2-[2-[2-(4-Octylphenoxy)ethoxy]ethoxy]ethanol | 51437-91-3 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 131. | 3,6,9,12,15-Pentaoxaheptadecan-1-ol, 17-[4-(1,1,3,3-tetramethylbutyl)phenoxy]- | 2497-58-7 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 132. | Ethanol, 2-[2-[2-[4-(1,1,3,3-tetramethylbutyl)phenoxy]ethoxy]ethoxy]- | 2315-62-0 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 133. | Ethanol, 2-[2-[2-[2-[4-(1,1,3,3-tetramethylbutyl)phenoxy]ethoxy]ethoxy]ethoxy]- | 2315-63-1 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 134. | 3,6,9,12-Tetraoxatetradecan-1-ol, 14-[4-(1,1,3,3-tetramethylbutyl)phenoxy]- | 2315-64-2 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 135. | 3,6,9,12,15,18,21,24-Octaoxahexacosan-1-ol, 26-[4-(1,1,3,3-tetramethylbutyl)phenoxy]- | 2315-65-3 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 136. | 3,6,9,12,15,18,21,24,27-Nonaoxanonacosan-1-ol, 29-[4-(1,1,3,3-tetramethylbutyl)phenoxy]- | 2315-66-4 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 137. | Ethanol, 2-[3-(1,1,3,3-tetramethylbutyl)phenoxy]- | 1026254-24-9 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 138. | Ethanol, 2-[2-(1,1,3,3-tetramethylbutyl)phenoxy]- | 84658-53-7 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 139. | Ethanol, 2-[2-(octylphenoxy)ethoxy]- | 27176-92-7 | Endocrine disrupting properties (REACH Article 57(f) – Environment) | ||
| 140. | N, N-Dimethylformamide | N, N-dimethylformamide; Dimethyl formamide, DMF | 68-12-2 | 200-679-5 | Toxic to reproduction cat.1B |
| 141. | Prop-2-enamide | Acrylamide; 2-propenamide | 79-06-1 | 201-173-7 | Carcinogenic cat.1B/ Mutagenic cat.1B |
| 142. | Pyridine, alkyl derivatives, with a content of ≥ 0,1 % benzene (EC No 200-753-7) | 68391-11-7 | 269-929-9 | Carcinogenic cat.1A/ Mutagenic cat.1B | |
| 143. | Quinoline | Quinoline | 91-22-5 | 202-051-6 | Carcinogenic cat.1B |
| 144. | Tetrahydrofurfuryl Alcohol | Tetrahydrofurfuryl alcohol; 2-Furanmethanol, tetrahydro- | 97-99-4 | 202-625-6 | Toxic to reproduction cat.1B |
| (1) The limit for the acceptable presence of the substances listed in the table as unintentional impurity in the finished product is 0,1 % (weight by weight (w/w)) except where stated otherwise in this Annex. (2) The limit for the acceptable presence of this substance as unintentional impurity in the finished product is 0,01 % (weight by weight (w/w)), corresponding to the specific concentration limit set in Annex VI to Regulation (EC) No 1272/2008. |
ANNEX IV
Comparative assessment pursuant to Article 50
1. Conditions for comparative assessment
Where refusal or withdrawal of an authorisation of a plant protection product in favour of an alternative plant protection product or a non-chemical control or prevention method is considered, referred to as ‘substitution’, the alternative must, in the light of scientific and technical knowledge, show significantly lower risk to health or the environment. An assessment of the alternative shall be performed to demonstrate whether it can be used with similar effect on the target organism and without significant economic and practical disadvantages to the user or not.
Further conditions for refusal or withdrawal of an authorisation are as follows:
(a) substitution shall be applied only where other methods or the chemical diversity of the active substances is sufficient to minimise the occurrence of resistance in the target organism;
(b) substitution shall be applied only to plant protection products where their use presents a significantly higher level of risk to human health or the environment; and
(c) substitution shall be applied only after allowing for the possibility, where necessary, of acquiring experience from use in practice, where not already available.
2. Significant difference in risk
A significant difference in risk shall be identified on a case-by-case basis by the competent authorities. The properties of the active substance and plant protection product, and the possibility of exposure of different population subgroups (professional or non-professional users, bystanders, workers, residents, specific vulnerable groups or consumers) directly or indirectly through food, feed, drinking water or the environment shall be taken into account. Other factors such as the stringency of imposed restrictions on use and prescribed personal protective equipment shall also be considered.
For the environment, if relevant, a factor of at least 10 for the toxicity/exposure ratio (TER) of different plant protection products is considered a significant difference in risk.
3. Significant practical or economic disadvantages
Significant practical or economic disadvantage to the user is defined as a major quantifiable impairment of working practices or business activity leading to inability to maintain sufficient control of the target organism. Such a major impairment might be, for example, where no technical facilities for the use of the alternative are available or economically feasible.
Where a comparative assessment indicates that restrictions on and/or prohibitions of use of a plant protection product could cause such disadvantage, then this shall be taken into account in the decision-making process. This situation shall be substantiated.
The comparative assessment shall take authorised minor uses into account.
ANNEX V
Repealed Directives and their successive amendments as referred to in Article 83
A. Directive 91/414/EEC
| Acts amending Directive 91/414/EEC | Deadline for transposition |
|---|---|
| Directive 93/71/EEC | 3 August 1994 |
| Directive 94/37/EC | 31 July 1995 |
| Directive 94/79/EC | 31 January 1996 |
| Directive 95/35/EC | 30 June 1996 |
| Directive 95/36/EC | 30 April 1996 |
| Directive 96/12/EC | 31 March 1997 |
| Directive 96/46/EC | 30 April 1997 |
| Directive 96/68/EC | 30 November 1997 |
| Directive 97/57/EC | 1 October 1997 |
| Directive 2000/80/EC | 1 July 2002 |
| Directive 2001/21/EC | 1 July 2002 |
| Directive 2001/28/EC | 1 August 2001 |
| Directive 2001/36/EC | 1 May 2002 |
| Directive 2001/47/EC | 31 December 2001 |
| Directive 2001/49/EC | 31 December 2001 |
| Directive 2001/87/EC | 31 March 2002 |
| Directive 2001/99/EC | 1 January 2003 |
| Directive 2001/103/EC | 1 April 2003 |
| Directive 2002/18/EC | 30 June 2003 |
| Directive 2002/37/EC | 31 August 2003 |
| Directive 2002/48/EC | 31 December 2002 |
| Directive 2002/64/EC | 31 March 2003 |
| Directive 2002/81/EC | 30 June 2003 |
| Directive 2003/5/EC | 30 April 2004 |
| Directive 2003/23/EC | 31 December 2003 |
| Directive 2003/31/EC | 30 June 2004 |
| Directive 2003/39/EC | 30 September 2004 |
| Directive 2003/68/EC | 31 March 2004 |
| Directive 2003/70/EC | 30 November 2004 |
| Directive 2003/79/EC | 30 June 2004 |
| Directive 2003/81/EC | 31 January 2005 |
| Directive 2003/82/EC | 30 July 2004 |
| Directive 2003/84/EC | 30 June 2004 |
| Directive 2003/112/EC | 30 April 2005 |
| Directive 2003/119/EC | 30 September 2004 |
| Regulation (EC) No 806/2003 | — |
| Directive 2004/20/EC | 31 July 2005 |
| Directive 2004/30/EC | 30 November 2004 |
| Directive 2004/58/EC | 31 August 2005 |
| Directive 2004/60/EC | 28 February 2005 |
| Directive 2004/62/EC | 31 March 2005 |
| Directive 2004/66/EC | 1 May 2004 |
| Directive 2004/71/EC | 31 March 2005 |
| Directive 2004/99/EC | 30 June 2005 |
| Directive 2005/2/EC | 30 September 2005 |
| Directive 2005/3/EC | 30 September 2005 |
| Directive 2005/25/EC | 28 May 2006 |
| Directive 2005/34/EC | 30 November 2005 |
| Directive 2005/53/EC | 31 August 2006 |
| Directive 2005/54/EC | 31 August 2006 |
| Directive 2005/57/EC | 31 October 2006 |
| Directive 2005/58/EC | 31 May 2006 |
| Directive 2005/72/EC | 31 December 2006 |
| Directive 2006/5/EC | 31 March 2007 |
| Directive 2006/6/EC | 31 March 2007 |
| Directive 2006/10/EC | 30 September 2006 |
| Directive 2006/16/EC | 31 January 2007 |
| Directive 2006/19/EC | 30 September 2006 |
| Directive 2006/39/EC | 31 July 2007 |
| Directive 2006/41/EC | 31 January 2007 |
| Directive 2006/45/EC | 18 September 2006 |
| Directive 2006/64/EC | 31 October 2007 |
| Directive 2006/74/EC | 30 November 2007 |
| Directive 2006/75/EC | 31 March 2007 |
| Directive 2006/85/EC | 31 January 2008 |
| Directive 2006/104/EC | 1 January 2007 |
| Directive 2006/131/EC | 30 June 2007 |
| Directive 2006/132/EC | 30 June 2007 |
| Directive 2006/133/EC | 30 June 2007 |
| Directive 2006/134/EC | 30 June 2007 |
| Directive 2006/135/EC | 30 June 2007 |
| Directive 2006/136/EC | 30 June 2007 |
| Directive 2007/5/EC | 31 March 2008 |
| Directive 2007/6/EC | 31 July 2007 |
| Directive 2007/21/EC | 12 December 2007 |
| Directive 2007/25/EC | 31 March 2008 |
| Directive 2007/31/EC | 1 September 2007 |
| Directive 2007/50/EC | 31 May 2008 |
| Directive 2007/52/EC | 31 March 2008 |
| Directive 2007/76/EC | 30 April 2009 |
| Directive 2008/40/EC | 30 April 2009 |
| Directive 2008/41/EC | 30 June 2009 |
| Directive 2008/45/EC | 8 August 2008 |
| Directive 2008/66/EC | 30 June 2009 |
B. Directive 79/117/EEC
| Acts amending Directive 79/117/EEC | Deadline for transposition |
|---|---|
| Directive 83/131/EEC | 1 October 1984 |
| Directive 85/298/EEC | 1 January 1986 |
| Directive 86/214/EEC | — |
| Directive 86/355/EEC | 1 July 1987 |
| Directive 87/181/EEC | 1 January 1988 and 1 January 1989 |
| Directive 87/477/EEC | 1 January 1988 |
| Directive 89/365/EEC | 31 December 1989 |
| Directive 90/335/EEC | 1 January 1991 |
| Directive 90/533/EEC | 31 December 1990 and 30 September 1990 |
| Directive 91/188/EEC | 31 March 1992 |
| Regulation (EC) No 807/2003 | — |
| Regulation (EC) No 850/2004 | — |
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