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Made by Regulation (EU) 2020/2081 32020R2081 on EUR-Lex (external, EUR-Lex) · Regulation (EU) 2019/1148 32019R1148 on EUR-Lex (external, EUR-Lex) · Regulation (EU) 2021/57 32021R0057 on EUR-Lex (external, EUR-Lex) · Regulation (EU) 2020/2096 32020R2096 on EUR-Lex (external, EUR-Lex)
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2 changes in this version
Consolidated versions 02006R1907-20210101 → 02006R1907-20210215. v1 is the previous version, v2 this one.The date in a version's code is the date EUR-Lex gives that consolidated text, which can differ from its in-force date: this version, coded 20210215, is in force from 4 January 2021.
Everything Regulation (EU) 2020/2081 changed
Everything Regulation (EU) 2019/1148 changed
What changed
Annex XIV LIST OF SUBSTANCES SUBJECT TO AUTHORISATION, Modified§
dates added to the text: 2017-04-05, 2022-06-22, 2023-12-22
Not in every listWhat this means
Found in the text, but not every source lists it — the text comparison found this change; the EU's own amendment metadata does not list it. The source that does not name it is the EU's own amendment metadata. Both are shown; neither is overruled.
Explanation, written by a model and checked against the cited text
A footnote citing Regulation (EU) 2017/746 on in vitro diagnostic medical devices has been added to the list of reference notes at the top of the Annex.
Entry 42, concerning 4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated, has had its latest application date and sunset date columns replaced with a split provision: the original single dates are kept as point (a), and a new point (b) sets out a later derogated date and describes specific uses tied to medicinal products and medical devices under listed directives and regulations, including Regulation (EU) 2017/746, in connection with the diagnosis, treatment or prevention of COVID-19.
Cited: Annex XIV, v2 (external, EUR-Lex) · Annex XIV, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Each CAS and EC number in these tables links to its own page, which lists every entry that prints it across the acts this record holds.
0 entries added, 1 amended, 0 removed.
1 entry amended
| Identifiers | Version | Entry Nr | Substance | Intrinsic property(ies) referred to in Article 57 | Transitional arrangements | Exempted (categories of) uses | Review periods | |
|---|---|---|---|---|---|---|---|---|
| Latest application date | Sunset date | |||||||
| Entry 42 | Before | 42. | 4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated (covering well-defined substances and UVCB substances, polymers and homologues) EC No — CAS No — | Endocrine disrupting properties (Article 57(f) — environment) | 4 July 2019 | 4 January 2021 | — | — |
| After | 42. | 4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated (covering well-defined substances and UVCB substances, polymers and homologues) EC No — CAS No — | Endocrine disrupting properties (Article 57(f) — environment) | (a) 4 July 2019 ; (b) by way of derogation from point (a), 22 June 2022 for uses as follows: for the research, development and production of medicinal products falling within the scope of Directive 2001/83/EC or medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746 of the European Parliament and of the Council , in view of their use for the diagnosis, treatment or prevention of the coronavirus disease (COVID-19), in medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, for the diagnosis, treatment or prevention of COVID-19. | (a) 4 January 2021 ; (b) by way of derogation from point (a), 22 December 2023 for uses as follows: for the research, development and production of medicinal products falling within the scope of Directive 2001/83/EC or medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, in view of their use for the diagnosis, treatment or prevention of COVID-19, in medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, for the diagnosis, treatment or prevention of COVID-19. | — | — | |
Text from EUR-Lex, before and after
Previous version, in force 1 January 2021 02006R1907-20210101 → this version, in force 4 January 2021 02006R1907-20210215
ANNEX XIV LIST OF SUBSTANCES SUBJECT TO AUTHORISATION Date referred to in Article 58(1)(c)(ii) of Regulation (EC) No 1907/2006. Date referred to in Article 58(1)(c)(i) of Regulation (EC) No 1907/2006. 1 September 2021 for the use of the substance in the production of spare parts as articles or as complex products for the repair of articles or complex products, the production of which ceased or will have ceased before the sunset date indicated in the entry for that substance, where that substance was used in the production of those articles or complex products and these cannot function as intended without that spare part and the spare part cannot be produced without that substance, and for the use of the substance (on its own or in a mixture) for the repair of such articles or complex products where that substance on its own or in a mixture was used in the production of those articles or complex products and they cannot be repaired otherwise than by using that substance. 1 March 2023 for the use of the substance in the production of spare parts as articles or as complex products for the repair of articles or complex products the production of which ceased or will have ceased before the sunset date indicated in the entry for that substance, where that substance was used in the production of those articles or complex products and these cannot function as intended without those spare parts and the spare part cannot be produced without that substance, and for the use of the substance (on its own or in a mixture) for the repair of such articles or complex products, where that substance on its own or in a mixture was used in the production of those articles or complex products and they cannot be repaired otherwise than by using that substance. Does not meet the criteria for identification as a carcinogen if it contains < 0,005 % (w/w) benzo[a]pyrene (Einecs No 200-028-5). Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176). Entry Nr Substance Intrinsic property(ies) referred to in Article 57 Transitional arrangements Exempted (categories of) uses Review periods Latest application date Sunset date 1. 5-tert-butyl-2,4,6-trinitro-m-xylene (Musk xylene) EC No 201-329-4 CAS No 81-15-2 vPvB 21 February 2013 21 August 2014 — — 2. 4,4’-Diaminodiphenylmethane (MDA) EC No 202-974-4 CAS No 101-77-9 Carcinogenic (category 1B) 21 … 686 unchanged words … 2019 4 October 2020 — — 41. Pitch, coal tar, high temp. EC No 266-028-2 CAS No 65996-93-2 Carcinogenic (category 1B), PBT, vPvB 4 April 2019 4 October 2020 — — 42. 4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated (covering well-defined substances and UVCB substances, polymers and homologues) EC No — CAS No — Endocrine disrupting properties (Article 57(f) — environment) (a) 4 July 2019 ; (b) by way of derogation from point (a), 22 June 2022 for uses as follows: for the research, development and production of medicinal products falling within the scope of Directive 2001/83/EC or medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746 of the European Parliament and of the Council , in view of their use for the diagnosis, treatment or prevention of the coronavirus disease (COVID-19), in medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, for the diagnosis, treatment or prevention of COVID-19. (a) 4 January 2021 ; (b) by way of derogation from point (a), 22 December 2023 for uses as follows: for the research, development and production of medicinal products falling within the scope of Directive 2001/83/EC or medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, in view of their use for the diagnosis, treatment or prevention of COVID-19, in medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, for the diagnosis, treatment or prevention of COVID-19. — — 43. 4-Nonylphenol, branched and linear, ethoxylated (substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof) EC No — CAS No — Endocrine disrupting properties (Article 57(f) — environment) 4 July 2019 4 January 2021 — — 44. 1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear EC No: 271-093-5 CAS No: 68515-50-4 Toxic for reproduction (category 1B) 27 August 2021 27 February 2023 — — 45. Dihexyl phthalate EC No: 201-559-5 CAS No: 84-75-3 Toxic for reproduction (category 1B) 27 August 2021 27 February 2023 — — 46. 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0,3 % of dihexyl phthalate (EC No 201-559-5) EC No: 271-094-0; 272-013-1 CAS No: 68515-51-5; 68648-93-1 Toxic for reproduction (category 1B) 27 August 2021 27 February 2023 — — 47. Trixylyl phosphate EC No: 246-677-8 CAS No: 25155-23-1 Toxic for reproduction (category 1B) 27 November 2021 27 May 2023 — — 48. Sodium perborate; perboric acid, sodium salt EC No: 239-172-9; 234-390-0 CAS No: - Toxic for reproduction (category 1B) 27 November 2021 27 May 2023 — — 49. Sodium peroxometaborate EC No: 231-556-4 CAS No: 7632-04-4 Toxic for reproduction (category 1B) 27 November 2021 27 May 2023 — — 50. 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof] EC No: - CAS No: - vPvB 27 February 2022 27 August 2023 — — 51. 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328) EC No: 247-384-8 CAS No: 25973-55-1 PBT, vPvB 27 May 2022 27 November 2023 — — 52. 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327) EC No: 223-383-8 CAS No: 3864-99-1 vPvB 27 May 2022 27 November 2023 — — 53. 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350) EC No: 253-037-1 CAS No: 36437-37-3 vPvB 27 May 2022 27 November 2023 — — 54. 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320) EC No: 223-346-6 CAS No: 3846-71-7 PBT, vPvB 27 May 2022 27 November 2023 — —
Annex XVII RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, MIXTURES AND ARTICLES, Modified§
dates added to the text: 2009-11-30, 2021-01-04, 2021-02-15, 2021-08-15, 2022-01-04, 2023-01-04, 2023-02-15, 2023-08-15, 2024-02-15
Explanation, written by a model and checked against the cited text
A new reference to Regulation (EC) No 1223/2009 on cosmetic products has been added to the list of cited instruments at the start of the Annex.
In entry 3, the hazard labelling references were changed from citing both R65 and H304 to citing H304 alone in several places, and the phrase 'implementation of other Community provisions relating to the classification, packaging and labelling' was replaced with 'implementation of other Union provisions relating to the classification, labelling and packaging'.
In entry 30, a new derogation point covering devices covered by Regulation (EU) 2017/745 was added after the existing Appendix 11 derogation; the visible text is truncated beyond this point in both versions, so further differences in the appendices cannot be described.
Cited: Annex XVII, v2 (external, EUR-Lex) · Annex XVII, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
91 entries added, 3 amended, 0 removed.
6 rows in the previous version and 7 in this one carry no key and are not compared.
91 entries added
| Identifiers | Column 1 Designation of the substance, of the group of substances or of the mixture | Column 2 Conditions of restriction |
|---|---|---|
| Entry 75 | 75. Substances falling within one or more of the following points: (a) substances classified as any of the following in Part 3 of Annex VI to Regulation (EC) No 1272/2008: carcinogen category 1A, 1B or 2, or germ cell mutagen category 1A, 1B or 2, but excluding any such substances classified due to effects only following exposure by inhalation reproductive toxicant category 1A, 1B or 2 but excluding any such substances classified due to effects only following exposure by inhalation skin sensitiser category 1, 1A or 1B skin corrosive category 1, 1A, 1B or 1C or skin irritant category 2 serious eye damage category 1 or eye irritant category 2 (b) substances listed in Annex II to Regulation (EC) No 1223/2009 of the European Parliament and of the Council (c) substances listed in Annex IV to Regulation (EC) No 1223/2009 for which a condition is specified in at least one of the columns g, h and i of the table in that Annex (d) substances listed in Appendix 13 to this Annex. The ancillary requirements in paragraphs 7 and 8 of column 2 of this entry apply to all mixtures for use for tattooing purposes, whether or not they contain a substance falling within points (a) to (d) of this column of this entry. | 1. Shall not be placed on the market in mixtures for use for tattooing purposes, and mixtures containing any such substances shall not be used for tattooing purposes, after 4 January 2022 if the substance or substances in question is or are present in the following circumstances: (a) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as carcinogen category 1A, 1B or 2, or germ cell mutagen category 1A, 1B or 2, the substance is present in the mixture in a concentration equal to or greater than 0,00005 % by weight; (b) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as reproductive toxicant category 1A, 1B or 2, the substance is present in the mixture in a concentration equal to or greater than 0,001 % by weight; (c) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as skin sensitiser category 1, 1A or 1B, the substance is present in the mixture in a concentration equal to or greater than 0,001 % by weight; (d) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as skin corrosive category 1, 1A, 1B or 1C or skin irritant category 2, or as serious eye damage category 1 or eye irritant category 2, the substance is present in the mixture in a concentration equal to or greater than: (i) 0,1 % by weight, if the substance is used solely as a pH regulator; (ii) 0,01 % by weight, in all other cases; (e) in the case of a substance listed in Annex II to Regulation (EC) No 1223/2009 , the substance is present in the mixture in a concentration equal to or greater than 0,00005 % by weight; (f) in the case of a substance for which a condition of one or more of the following kinds is specified in column g (Product type, Body parts) of the table in Annex IV to Regulation (EC) No 1223/2009, the substance is present in the mixture in a concentration equal to or greater than 0,00005 % by weight: (i) Rinse-off products; (ii) Not to be used in products applied on mucous membranes; (iii) Not to be used in eye products; (g) in the case of a substance for which a condition is specified in column h (Maximum concentration in ready for use preparation) or column i (Other) of the table in Annex IV to Regulation (EC) No 1223/2009, the substance is present in the mixture in a concentration, or in some other way, that does not accord with the condition specified in that column; (h) in the case of a substance listed in Appendix 13 to this Annex, the substance is present in the mixture in a concentration equal to or greater than the concentration limit specified for that substance in that Appendix. 2. For the purposes of this entry use of a mixture for tattooing purposes means injection or introduction of the mixture into a person’s skin, mucous membrane or eyeball, by any process or procedure (including procedures commonly referred to as permanent make-up, cosmetic tattooing, micro-blading and micro-pigmentation), with the aim of making a mark or design on his or her body. 3. If a substance not listed in Appendix 13 falls within more than one of points (a) to (g) of paragraph 1, the strictest concentration limit laid down in the points in question shall apply to that substance. If a substance listed in Appendix 13 also falls within one or more of points (a) to (g) of paragraph 1, the concentration limit laid down in point (h) of paragraph 1 shall apply to that substance. 4. By way of derogation, paragraph 1 shall not apply to the following substances until 4 January 2023: (a) Pigment Blue 15:3 (CI 74160, EC No 205-685-1, CAS No 147-14-8); (b) Pigment Green 7 (CI 74260, EC No 215-524-7, CAS No 1328-53-6). 5. If Part 3 of Annex VI to Regulation (EC) No 1272/2008 is amended after 4 January 2021 to classify or re-classify a substance such that the substance then becomes caught by point (a), (b), (c) or (d) of paragraph 1 of this entry, or such that it then falls within a different one of those points from the one within which it fell previously, and the date of application of that new or revised classification is after the date referred to in paragraph 1 or, as the case may be, paragraph 4 of this entry, that amendment shall, for the purposes of applying this entry to that substance, be treated as taking effect on the date of application of that new or revised classification. 6. If Annex II or Annex IV to Regulation (EC) No 1223/2009 is amended after 4 January 2021 to list or change the listing of a substance such that the substance then becomes caught by point (e), (f) or (g) of paragraph 1 of this entry, or such that it then falls within a different one of those points from the one within which it fell previously, and the amendment takes effect after the date referred to in paragraph 1 or, as the case may be, paragraph 4 of this entry, that amendment shall, for the purposes of applying this entry to that substance, be treated as taking effect from the date falling 18 months after entry into force of the act by which that amendment was made. 7. Suppliers placing a mixture on the market for use for tattooing purposes shall ensure that, after 4 January 2022, the mixture is marked with the following information: (a) the statement Mixture for use in tattoos or permanent make-up; (b) a reference number to uniquely identify the batch; (c) the list of ingredients in accordance with the nomenclature established in the glossary of common ingredient names pursuant to Article 33 of Regulation (EC) No 1223/2009, or in the absence of a common ingredient name, the IUPAC name. In the absence of a common ingredient name or IUPAC name, the CAS and EC number. Ingredients shall be listed in descending order by weight or volume of the ingredients at the time of formulation. Ingredient means any substance added during the process of formulation and present in the mixture for use for tattooing purposes. Impurities shall not be regarded as ingredients. If the name of a substance, used as ingredient within the meaning of this entry, is already required to be stated on the label in accordance with Regulation (EC) No 1272/2008, that ingredient does not need to be marked in accordance with this Regulation; (d) the additional statement pH regulator for substances falling under point (d)(i) of paragraph 1; (e) the statement "Contains nickel. Can cause allergic reactions." if the mixture contains nickel below the concentration limit specified in Appendix 13; (f) the statement "Contains chromium (VI). Can cause allergic reactions." if the mixture contains chromium (VI) below the concentration limit specified in Appendix 13; (g) safety instructions for use insofar as they are not already required to be stated on the label by Regulation (EC) No 1272/2008. The information shall be clearly visible, easily legible and marked in a way that is indelible. The information shall be written in the official language(s) of the Member State(s) where the mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise. Where necessary because of the size of the package, the information listed in the first subparagraph, except for point (a), shall be included instead in the instructions for use. Before using a mixture for tattooing purposes, the person using the mixture shall provide the person undergoing the procedure with the information marked on the package or included in the instructions for use pursuant to this paragraph. 8. Mixtures that do not contain the statement Mixture for use in tattoos or permanent make-up shall not be used for tattooing purposes. 9. This entry does not apply to substances that are gases at temperature of 20 °C and pressure of 101,3 kPa, or generate a vapour pressure of more than 300 kPa at temperature of 50 °C, with the exception of formaldehyde (CAS No 50-00-0, EC No 200-001-8). 10. This entry does not apply to the placing on the market of a mixture for use for tattooing purposes, or to the use of a mixture for tattooing purposes, when placed on the market exclusively as a medical device or an accessory to a medical device, within the meaning of Regulation (EU) 2017/745, or when used exclusively as a medical device or an accessory to a medical device, within the same meaning. Where the placing on the market or use may not be exclusively as a medical device or an accessory to a medical device, the requirements of Regulation (EU) 2017/745 and of this Regulation shall apply cumulatively. |
| Identifiers | Substance name | EC No | CAS No | Concentration limit (by weight) |
|---|---|---|---|---|
| CAS No 50-32-8, 63466-71-7CAS 50-32-8CAS 63466-71-7EC 200-028-5 | Benzo[a]pyrene | 200-028-5 | 50-32-8, 63466-71-7 | 0,0000005 % |
| CAS No 60-09-3CAS 60-09-3EC 200-453-6 | 4-Aminoazobenzene | 200-453-6 | 60-09-3 | 0,0005 % |
| CAS No 60-11-7CAS 60-11-7EC 200-455-7 | Solvent Yellow 2 | 200-455-7 | 60-11-7 | 0,1 % |
| CAS No 62-53-3CAS 62-53-3EC 200-539-3 | Aniline | 200-539-3 | 62-53-3 | 0,0005 % |
| CAS No 67-56-1CAS 67-56-1EC 200-659-6 | Methanol | 200-659-6 | 67-56-1 | 11 % |
| CAS No 85-86-9CAS 85-86-9EC 201-638-4 | Solvent Red 23 (SR23)/CI 26100 | 201-638-4 | 85-86-9 | 0,1 % |
| CAS No 87-62-7CAS 87-62-7EC 201-758-7 | 2,6-xylidine | 201-758-7 | 87-62-7 | 0,0005 % |
| CAS No 90-04-0CAS 90-04-0EC 201-963-1 | o-Anisidine | 201-963-1 | 90-04-0 | 0,0005 % |
| CAS No 91-59-8CAS 91-59-8EC 202-080-4 | 2-naphthylamine | 202-080-4 | 91-59-8 | 0,0005 % |
| CAS No 91-94-1CAS 91-94-1EC 202-109-0 | 3,3'-dichlorobenzidine | 202-109-0 | 91-94-1 | 0,0005 % |
| CAS No 92-67-1CAS 92-67-1EC 202-177-1 | Biphenyl-4-ylamine | 202-177-1 | 92-67-1 | 0,0005 % |
| CAS No 92-87-5CAS 92-87-5EC 202-199-1 | Benzidine | 202-199-1 | 92-87-5 | 0,0005 % |
| CAS No 95-53-4CAS 95-53-4EC 202-429-0 | o-toluidine | 202-429-0 | 95-53-4 | 0,0005 % |
| CAS No 95-68-1CAS 95-68-1EC 202-440-0 | 2,4-xylidine | 202-440-0 | 95-68-1 | 0,0005 % |
| CAS No 95-69-2CAS 95-69-2EC 202-441-6 | 4-chloro-o-toluidine | 202-441-6 | 95-69-2 | 0,0005 % |
| CAS No 95-70-5CAS 95-70-5EC 202-442-1 | 2-methyl-p-phenylenediamine | 202-442-1 | 95-70-5 | 0,0005 % |
| CAS No 95-80-7CAS 95-80-7EC 202-453-1 | 4-methyl-m- phenylenediamine | 202-453-1 | 95-80-7 | 0,0005 % |
| CAS No 97-56-3CAS 97-56-3EC 202-591-2 | 4-o-tolylazo-o-toluidine | 202-591-2 | 97-56-3 | 0,0005 % |
| CAS No 99-55-8CAS 99-55-8EC 202-765-8 | 5-nitro-o-toluidine | 202-765-8 | 99-55-8 | 0,0005 % |
| CAS No 101-14-4CAS 101-14-4EC 202-918-9 | 4,4'- methylene-bis-[2-chloro aniline] | 202-918-9 | 101-14-4 | 0,0005 % |
| CAS No 101-77-9CAS 101-77-9EC 202-974-4 | 4,4'-methylenedianiline | 202-974-4 | 101-77-9 | 0,0005 % |
| CAS No 101-80-4CAS 101-80-4EC 202-977-0 | 4,4'-oxydianiline | 202-977-0 | 101-80-4 | 0,0005 % |
| CAS No 106-47-8CAS 106-47-8EC 203-401-0 | 4-chloroaniline | 203-401-0 | 106-47-8 | 0,0005 % |
| CAS No 106-49-0CAS 106-49-0EC 203-403-1 | p-toluidine | 203-403-1 | 106-49-0 | 0,0005 % |
| CAS No 106-50-3CAS 106-50-3EC 203-404-7 | p-Phenylenediamine | 203-404-7 | 106-50-3 | 0,0005 % |
| CAS No 119-90-4CAS 119-90-4EC 204-355-4 | 3,3'-dimethoxybenzidine | 204-355-4 | 119-90-4 | 0,0005 % |
| CAS No 119-93-7CAS 119-93-7EC 204-358-0 | 4,4'-bi-o-toluidine | 204-358-0 | 119-93-7 | 0,0005 % |
| CAS No 120-71-8CAS 120-71-8EC 204-419-1 | 6-methoxy-m-toluidine | 204-419-1 | 120-71-8 | 0,0005 % |
| CAS No 121-57-3CAS 121-57-3EC 204-482-5 | Sulphanilic acid | 204-482-5 | 121-57-3 | 0,0005 % |
| CAS No 137-17-7CAS 137-17-7EC 205-282-0 | 2,4,5-trimethylaniline | 205-282-0 | 137-17-7 | 0,0005 % |
| CAS No 139-65-1CAS 139-65-1EC 205-370-9 | 4,4'-Thiodianiline | 205-370-9 | 139-65-1 | 0,0005 % |
| CAS No 399-95-1CAS 399-95-1EC 402-230-0 | 4-amino-3-fluorophenol | 402-230-0 | 399-95-1 | 0,0005 % |
| CAS No 615-05-4CAS 615-05-4EC 210-406-1 | 4-methoxy-m- phenylenediamine | 210-406-1 | 615-05-4 | 0,0005 % |
| CAS No 838-88-0CAS 838-88-0EC 212-658-8 | 4,4'-methylenedi-o-toluidine | 212-658-8 | 838-88-0 | 0,0005 % |
| CAS No 989-38-8CAS 989-38-8EC 213-584-9 | Basic Red 1 | 213-584-9 | 989-38-8 | 0,1 % |
| CAS No 1229-55-6CAS 1229-55-6EC 214-968-9 | Solvent Red 1 (SR1)/CI 12150 | 214-968-9 | 1229-55-6 | 0,1 % |
| CAS No 1320-07-6CAS 1320-07-6EC 215-296-9 | Acid Orange 24 (AO24)/CI 20170 | 215-296-9 | 1320-07-6 | 0,1 % |
| CAS No 1325-82-2CAS 1325-82-2EC 603-635-7 | Pigment Violet 3 | 603-635-7 | 1325-82-2 | 0,1 % |
| CAS No 2512-29-0CAS 2512-29-0EC 219-730-8 | Pigment Yellow 1 (PY1)/CI 11680 | 219-730-8 | 2512-29-0 | 0,1 % |
| CAS No 2832-40-8CAS 2832-40-8EC 220-600-8 | Disperse Yellow 3/CI 11855 | 220-600-8 | 2832-40-8 | 0,1 % |
| CAS No 2872-52-8CAS 2872-52-8EC 220-704-3 | Disperse Red 1 | 220-704-3 | 2872-52-8 | 0,1 % |
| CAS No 3179-89-3CAS 3179-89-3EC 221-665-5 | Disperse Red 17 | 221-665-5 | 3179-89-3 | 0,1 % |
| CAS No 3520-72-7CAS 3520-72-7EC 222-530-3 | Pigment Orange 13 (PO13)/CI 21110 | 222-530-3 | 3520-72-7 | 0,1 % |
| CAS No 3761-53-3CAS 3761-53-3EC 223-178-3 | Acid Red 26 | 223-178-3 | 3761-53-3 | 0,1 % |
| CAS No 4129-84-4CAS 4129-84-4EC 223-942-6 | Acid Violet 17 | 223-942-6 | 4129-84-4 | 0,1 % |
| CAS No 5280-68-2CAS 5280-68-2EC 226-103-2 | Pigment Red 146 (PR146)/CI 12485 | 226-103-2 | 5280-68-2 | 0,1 % |
| CAS No 5413-75-2CAS 5413-75-2EC 226-502-1 | Acid Red 73 (AR73)/CI 27290 | 226-502-1 | 5413-75-2 | 0,1 % |
| CAS No 5468-75-7CAS 5468-75-7EC 226-789-3 | Pigment Yellow 14 (PY14)/CI 21095 | 226-789-3 | 5468-75-7 | 0,1 % |
| CAS No 5567-15-7CAS 5567-15-7EC 226-939-8 | Pigment Yellow 83 (PY83)/CI 21108 | 226-939-8 | 5567-15-7 | 0,1 % |
41 more added entries
| Identifiers | Substance name | EC No | CAS No | Concentration limit (by weight) |
|---|---|---|---|---|
| CAS No 6041-94-7CAS 6041-94-7EC 227-930-1 | Pigment Red 2 (PR2)/CI 12310 | 227-930-1 | 6041-94-7 | 0,1 % |
| CAS No 6358-31-2CAS 6358-31-2EC 228-768-4 | Pigment Yellow 74 (PY74)/CI 11741 | 228-768-4 | 6358-31-2 | 0,1 % |
| CAS No 6358-37-8CAS 6358-37-8EC 226-789-3 | Pigment Yellow 55 (PY55)/CI 21096 | 226-789-3 | 6358-37-8 | 0,1 % |
| CAS No 6358-85-6CAS 6358-85-6EC 228-787-8 | Pigment Yellow 12 (PY12)/CI 21090 | 228-787-8 | 6358-85-6 | 0,1 % |
| CAS No 6373-73-5CAS 6373-73-5EC 228-919-4 | Disperse Yellow 9 | 228-919-4 | 6373-73-5 | 0,1 % |
| CAS No 6410-32-8CAS 6410-32-8EC 229-102-5 | Pigment Red 12 (PR12)/CI 12385 | 229-102-5 | 6410-32-8 | 0,1 % |
| CAS No 6410-38-4CAS 6410-38-4EC 229-104-6 | Pigment Red 9(PR9)/CI 12460 | 229-104-6 | 6410-38-4 | 0,1 % |
| CAS No 6410-39-5CAS 6410-39-5EC 229-105-1 | Pigment Red 15 (PR15)/CI 12465 | 229-105-1 | 6410-39-5 | 0,1 % |
| CAS No 6448-95-9CAS 6448-95-9EC 229-245-3 | Pigment Red 22 (PR22)/CI 12315 | 229-245-3 | 6448-95-9 | 0,1 % |
| CAS No 6471-50-7CAS 6471-50-7EC 229-314-8 | Pigment Red 14 (PR14)/CI 12380 | 229-314-8 | 6471-50-7 | 0,1 % |
| CAS No 6471-51-8CAS 6471-51-8EC 229-315-3 | Pigment Red 7 (PR7)/CI 12420 | 229-315-3 | 6471-51-8 | 0,1 % |
| CAS No 6505-28-8CAS 6505-28-8EC 229-388-1 | Pigment Orange16 (PO16)/CI 21160 | 229-388-1 | 6505-28-8 | 0,1 % |
| CAS No 6528-34-3CAS 6528-34-3EC 229-419-9 | Pigment Yellow 65 (PY65)/CI 11740 | 229-419-9 | 6528-34-3 | 0,1 % |
| CAS No 6535-46-2CAS 6535-46-2EC 229-440-3 | Pigment Red 112 (PR112)/CI 12370 | 229-440-3 | 6535-46-2 | 0,1 % |
| CAS No 6655-84-1CAS 6655-84-1EC 229-681-4 | Pigment Red 17 (PR17)/CI 12390 | 229-681-4 | 6655-84-1 | 0,1 % |
| CAS No 7439-92-1CAS 7439-92-1EC 231-100-4 | Lead | 231-100-4 | 7439-92-1 | 0,00007 % |
| CAS No 7439-97-6CAS 7439-97-6EC 231-106-7 | Mercury | 231-106-7 | 7439-97-6 | 0,00005 % |
| CAS No 7440-02-0CAS 7440-02-0EC 231-111-4 | Nickel | 231-111-4 | 7440-02-0 | 0,0005 % |
| CAS No 7440-31-5CAS 7440-31-5EC 231-141-8 | Organometallic tin | 231-141-8 | 7440-31-5 | 0,00005 % |
| CAS No 7440-36-0CAS 7440-36-0EC 231-146-5 | Antimony | 231-146-5 | 7440-36-0 | 0,00005 % |
| CAS No 7440-38-2CAS 7440-38-2EC 231-148-6 | Arsenic | 231-148-6 | 7440-38-2 | 0,00005 % |
| CAS No 7440-39-3CAS 7440-39-3EC 231-149-1 | Barium | 231-149-1 | 7440-39-3 | 0,05 % |
| CAS No 7440-43-9CAS 7440-43-9EC 231-152-8 | Cadmium | 231-152-8 | 7440-43-9 | 0,00005 % |
| CAS No 7440-47-3CAS 7440-47-3EC 231-157-5 | Chromium‡ | 231-157-5 | 7440-47-3 | 0,00005 % |
| CAS No 7440-48-4CAS 7440-48-4EC 231-158-0 | Cobalt | 231-158-0 | 7440-48-4 | 0,00005 % |
| CAS No 7440-50-8CAS 7440-50-8EC 231-159-6 | Copper | 231-159-6 | 7440-50-8 | 0,025 % |
| CAS No 7440-66-6CAS 7440-66-6EC 231-175-3 | Zinc | 231-175-3 | 7440-66-6 | 0,2 % |
| CAS No 7782-49-2CAS 7782-49-2EC 231-957-4 | Selenium | 231-957-4 | 7782-49-2 | 0,0002 % |
| CAS No 12222-75-2CAS 12222-75-2EC 602-260-6 | Disperse Blue 35 | 602-260-6 | 12222-75-2 | 0,1 % |
| CAS No 12223-01-7CAS 12223-01-7EC 602-285-2 | Disperse Blue 106 | 602-285-2 | 12223-01-7 | 0,1 % |
| CAS No 12223-33-5CAS 12223-33-5EC 602-312-8 | Disperse Orange 37 | 602-312-8 | 12223-33-5 | 0,1 % |
| CAS No 12225-18-2CAS 12225-18-2EC 235-427-3 | Pigment Yellow 97 (PY97)/CI 11767 | 235-427-3 | 12225-18-2 | 0,1 % |
| CAS No 12768-78-4CAS 12768-78-4EC 603-214-8 | Acid Green 16 | 603-214-8 | 12768-78-4 | 0,1 % |
| CAS No 15110-84-6, 14110-84-6CAS 15110-84-6EC 239-160-3 | Pigment Yellow 87 (PY87)/CI 21107:1 | 239-160-3 | 15110-84-6, 14110-84-6 | 0,1 % |
| CAS No 15793-73-4CAS 15793-73-4EC 239-898-6 | Pigment Orange 34 (PO34)/CI 21115 | 239-898-6 | 15793-73-4 | 0,1 % |
| CAS No 61932-63-6CAS 61932-63-6EC 612-766-9 | Pigment Red 210(PR210)/CI 12477 | 612-766-9 | 61932-63-6 | 0,1 % |
| CAS No 61951-51-7CAS 61951-51-7EC 612-788-9 | Disperse Blue 124 | 612-788-9 | 61951-51-7 | 0,1 % |
| CAS No 64070-98-0CAS 64070-98-0EC 264-654-0 | Pigment Violet 39 | 264-654-0 | 64070-98-0 | 0,1 % |
| CAS No 67990-05-0CAS 67990-05-0EC 268-028-8 | Pigment Red 269 (PR269)/CI 12466 | 268-028-8 | 67990-05-0 | 0,1 % |
| CAS No 85776-14-3CAS 85776-14-3 | Pigment Orange 74 (PO74) | 85776-14-3 | 0,1 % | |
| CAS No 293733-21-8CAS 293733-21-8 | 6-amino-2-ethoxynaphthaline | 293733-21-8 | 0,0005 % |
3 entries amended
| Identifiers | Version | Column 1 Designation of the substance, of the group of substances or of the mixture | Column 2 Conditions of restriction |
|---|---|---|---|
| Entry 3 | Before | 3. Liquid substances or mixtures which are regarded as dangerous in accordance with Directive 1999/45/EC or are fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008: (a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F; (b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10; (c) hazard class 4.1; (d) hazard class 5.1. | 1. Shall not be used in:
ornamental articles intended to produce light or colour effects by means of different phases, for example in ornamental lamps and ashtrays,
tricks and jokes,
games for one or more participants, or any article intended to be used as such, even with ornamental aspects,
2. Articles not complying with paragraph 1 shall not be placed on the market.
3. Shall not be placed on the market if they contain a colouring agent, unless required for fiscal reasons, or perfume, or both, if they:
can be used as fuel in decorative oil lamps for supply to the general public, |
| After | 3. Liquid substances or mixtures which are regarded as dangerous in accordance with Directive 1999/45/EC or are fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008: (a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F; (b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10; (c) hazard class 4.1; (d) hazard class 5.1. | 1. Shall not be used in: ornamental articles intended to produce light or colour effects by means of different phases, for example in ornamental lamps and ashtrays, tricks and jokes, games for one or more participants, or any article intended to be used as such, even with ornamental aspects, 2. Articles not complying with paragraph 1 shall not be placed on the market. 3. Shall not be placed on the market if they contain a colouring agent, unless required for fiscal reasons, or perfume, or both, if they: can be used as fuel in decorative oil lamps for supply to the general public, and present an aspiration hazard and are labelled with H304. 4. Decorative oil lamps for supply to the general public shall not be placed on the market unless they conform to the European Standard on Decorative oil lamps (EN 14059) adopted by the European Committee for Standardisation (CEN). 5. Without prejudice to the implementation of other Union provisions relating to the classification, labelling and packaging of substances and mixtures, suppliers shall ensure, before the placing on the market, that the following requirements are met: (a) lamp oils, labelled with H304, intended for supply to the general public are visibly, legibly and indelibly marked as follows: Keep lamps filled with this liquid out of the reach of children; and, by 1 December 2010, Just a sip of lamp oil – or even sucking the wick of lamps – may lead to life-threatening lung damage; (b) grill lighter fluids, labelled with H304, intended for supply to the general public are legibly and indelibly marked by 1 December 2010 as follows: Just a sip of grill lighter fluid may lead to life threatening lung damage; (c) lamps oils and grill lighters, labelled with H304, intended for supply to the general public are packaged in black opaque containers not exceeding 1 litre by 1 December 2010. 6. No later than 1 June 2014, the Commission shall request the European Chemicals Agency to prepare a dossier, in accordance with Article 69 of the present Regulation with a view to ban, if appropriate, grill lighter fluids and fuel for decorative lamps, labelled R65 or H304, intended for supply to the general public. 7. Natural or legal persons placing on the market for the first time lamp oils and grill lighter fluids, labelled with R65 or H304, shall by 1 December 2011, and annually thereafter, provide data on alternatives to lamp oils and grill lighter fluids labelled R65 or H304 to the competent authority in the Member State concerned. Member States shall make those data available to the Commission. | |
| Entry 28 | Before | 28. Substances which are classified as carcinogen category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 and are listed in Appendix 1 or Appendix 2, respectively. 29. Substances which are classified as germ cell mutagen category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 and are listed in Appendix 3 or Appendix 4, respectively. 30. Substances which are classified as reproductive toxicant category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 and are listed in Appendix 5 or Appendix 6, respectively. | Without prejudice to the other parts of this Annex the following shall apply to entries 28 to 30:
1. Shall not be placed on the market, or used,
as substances,
as constituents of other substances, or,
in mixtures,
for supply to the general public when the individual concentration in the substance or mixture is equal to or greater than:
either the relevant specific concentration limit specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008, or,
the relevant generic concentration limit specified in Part 3 of Annex I of Regulation (EC) No 1272/2008.
Without prejudice to the implementation of other Community provisions relating to the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that the packaging of such substances and mixtures is marked visibly, legibly and indelibly as follows:
Restricted to professional users.
2. By way of derogation, paragraph 1 shall not apply to:
(a) medicinal or veterinary products as defined by Directive 2001/82/EC and Directive 2001/83/EC;
(b) cosmetic products as defined by Directive 76/768/EEC;
(c) the following fuels and oil products:
motor fuels which are covered by Directive 98/70/EC,
mineral oil products intended for use as fuel in mobile or fixed combustion plants,
fuels sold in closed systems (e.g. liquid gas bottles);
(d) artists’ paints covered by Regulation (EC) No 1272/2008;
(e) the substances listed in Appendix 11, column 1, for the applications or uses listed in Appendix 11, column 2. Where a date is specified in column 2 of Appendix 11, the derogation shall apply until the said |
| After | 28. Substances which are classified as carcinogen category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 and are listed in Appendix 1 or Appendix 2, respectively. 29. Substances which are classified as germ cell mutagen category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 and are listed in Appendix 3 or Appendix 4, respectively. 30. Substances which are classified as reproductive toxicant category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 and are listed in Appendix 5 or Appendix 6, respectively. | Without prejudice to the other parts of this Annex the following shall apply to entries 28 to 30: 1. Shall not be placed on the market, or used, as substances, as constituents of other substances, or, in mixtures, for supply to the general public when the individual concentration in the substance or mixture is equal to or greater than: either the relevant specific concentration limit specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008, or, the relevant generic concentration limit specified in Part 3 of Annex I of Regulation (EC) No 1272/2008. Without prejudice to the implementation of other Community provisions relating to the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that the packaging of such substances and mixtures is marked visibly, legibly and indelibly as follows: Restricted to professional users. 2. By way of derogation, paragraph 1 shall not apply to: (a) medicinal or veterinary products as defined by Directive 2001/82/EC and Directive 2001/83/EC; (b) cosmetic products as defined by Directive 76/768/EEC; (c) the following fuels and oil products: motor fuels which are covered by Directive 98/70/EC, mineral oil products intended for use as fuel in mobile or fixed combustion plants, fuels sold in closed systems (e.g. liquid gas bottles); (d) artists’ paints covered by Regulation (EC) No 1272/2008; (e) the substances listed in Appendix 11, column 1, for the applications or uses listed in Appendix 11, column 2. Where a date is specified in column 2 of Appendix 11, the derogation shall apply until the said date; (f) devices covered by Regulation (EU) 2017/745. | |
| Entry 63CAS 7439-92-1EC 231-100-4 | Before | 63. Lead CAS No 7439-92-1 EC No 231-100-4 and its compounds | 1. Shall not be placed on the market or used in any individual part of jewellery articles if the concentration of lead (expressed as metal) in such a part is equal to or greater than 0,05 % by weight. 2. For the purposes of paragraph 1: (i) jewellery articles shall include jewellery and imitation jewellery articles and hair accessories, including: (a) bracelets, necklaces and rings; (b) piercing jewellery; (c) wrist watches and wrist-wear; (d) brooches and cufflinks; (ii) any individual part shall include the materials from which the jewellery is made, as well as the individual components of the jewellery articles. 3. Paragraph 1 shall also apply to individual parts when placed on the market or used for jewellery-making. 4. By way of derogation, paragraph 1 shall not apply to: (a) crystal glass as defined in Annex I (categories 1, 2, 3 and 4) to Council Directive 69/493/EEC ; (b) internal components of watch timepieces inaccessible to consumers; (c) non-synthetic or reconstructed precious and semiprecious stones (CN code 7103, as established by Regulation (EEC) No 2658/87), unless they have been treated with lead or its compounds or mixtures containing these substances; (d) enamels, defined as vitrifiable mixtures resulting from the fusion, vitrification or sintering of minerals melted at a temperature of at least 500 °C. 5. By way of derogation, paragraph 1 shall not apply to jewellery articles placed on the market for the first time before 9 October 2013 and jewellery articles produced before 10 December 1961. 6. By 9 October 2017, the Commission shall re-evaluate paragraphs 1 to 5 of this entry in the light of new scientific information, including the availability of alternatives and the migration of lead from the articles referred to in paragraph 1 and, if appropriate, modify this entry accordingly. 7. Shall not be placed on the market or used in articles supplied to the general public, if the concentration of lead (expressed as metal) in those articles or accessible parts thereof is equal to or greater than 0,05 % by weight, and those articles or accessible parts thereof may, during normal or reasonably foreseeable conditions of use, be placed in the mouth by children. That limit shall not apply where it can be demonstrated that the rate of lead release from such an article or any such accessible part of an article, whether coated or uncoated, does not exceed 0,05 μg/cm2 per hour (equivalent to 0,05 μg/g/h), and, for coated articles, that the coating is sufficient to ensure that this release rate is not exceeded for a period of at least two years of normal or reasonably foreseeable conditions of use of the article. For the purposes of this paragraph, it is considered that an article or accessible part of an article may be placed in the mouth by children if it is smaller than 5 cm in one dimension or has a detachable or protruding part of that size. 8. By way of derogation, paragraph 7 shall not apply to: (a) jewellery articles covered by paragraph 1; (b) crystal glass as defined in Annex I (categories 1, 2, 3 and 4) to Directive 69/493/EEC; (c) non-synthetic or reconstructed precious and semi-precious stones (CN code 7103 as established by Regulation (EEC) No 2658/87) unless they have been treated with lead or its compounds or mixtures containing these substances; (d) enamels, defined as vitrifiable mixtures resulting from the fusion, vitrification or sintering of mineral melted at a temperature of at least 500 °C; (e) keys and locks, including padlocks; (f) musical instruments; (g) articles and parts of articles comprising brass alloys, if the concentration of lead (expressed as metal) in the brass alloy does not exceed 0,5 % by weight; (h) the tips of writing instruments; (i) religious articles; (j) portable zinc-carbon batteries and button cell batteries; (k) articles within the scope of: (i) Directive 94/62/EC; (ii) Regulation (EC) No 1935/2004; (iii) Directive 2009/48/EC of the European Parliament and of the Council ; (iv) Directive 2011/65/EU of the European Parliament and of the Council 9. By 1 July 2019, the Commission shall re-evaluate paragraphs 7 and 8(e), (f), (i) and (j) of this entry in the light of new scientific information, including the availability of alternatives and the migration of lead from the articles referred to in paragraph 7, including the requirement on coating integrity, and, if appropriate, modify this entry accordingly. 10. By way of derogation paragraph 7 shall not apply to articles placed on the market for the first time before 1 June 2016. |
| After | 63. Lead CAS No 7439-92-1 EC No 231-100-4 and its compounds | 1. Shall not be placed on the market or used in any individual part of jewellery articles if the concentration of lead (expressed as metal) in such a part is equal to or greater than 0,05 % by weight. 2. For the purposes of paragraph 1: (i) jewellery articles shall include jewellery and imitation jewellery articles and hair accessories, including: (a) bracelets, necklaces and rings; (b) piercing jewellery; (c) wrist watches and wrist-wear; (d) brooches and cufflinks; (ii) any individual part shall include the materials from which the jewellery is made, as well as the individual components of the jewellery articles. 3. Paragraph 1 shall also apply to individual parts when placed on the market or used for jewellery-making. 4. By way of derogation, paragraph 1 shall not apply to: (a) crystal glass as defined in Annex I (categories 1, 2, 3 and 4) to Council Directive 69/493/EEC ; (b) internal components of watch timepieces inaccessible to consumers; (c) non-synthetic or reconstructed precious and semiprecious stones (CN code 7103, as established by Regulation (EEC) No 2658/87), unless they have been treated with lead or its compounds or mixtures containing these substances; (d) enamels, defined as vitrifiable mixtures resulting from the fusion, vitrification or sintering of minerals melted at a temperature of at least 500 °C. 5. By way of derogation, paragraph 1 shall not apply to jewellery articles placed on the market for the first time before 9 October 2013 and jewellery articles produced before 10 December 1961. 6. By 9 October 2017, the Commission shall re-evaluate paragraphs 1 to 5 of this entry in the light of new scientific information, including the availability of alternatives and the migration of lead from the articles referred to in paragraph 1 and, if appropriate, modify this entry accordingly. 7. Shall not be placed on the market or used in articles supplied to the general public, if the concentration of lead (expressed as metal) in those articles or accessible parts thereof is equal to or greater than 0,05 % by weight, and those articles or accessible parts thereof may, during normal or reasonably foreseeable conditions of use, be placed in the mouth by children. That limit shall not apply where it can be demonstrated that the rate of lead release from such an article or any such accessible part of an article, whether coated or uncoated, does not exceed 0,05 μg/cm2 per hour (equivalent to 0,05 μg/g/h), and, for coated articles, that the coating is sufficient to ensure that this release rate is not exceeded for a period of at least two years of normal or reasonably foreseeable conditions of use of the article. For the purposes of this paragraph, it is considered that an article or accessible part of an article may be placed in the mouth by children if it is smaller than 5 cm in one dimension or has a detachable or protruding part of that size. 8. By way of derogation, paragraph 7 shall not apply to: (a) jewellery articles covered by paragraph 1; (b) crystal glass as defined in Annex I (categories 1, 2, 3 and 4) to Directive 69/493/EEC; (c) non-synthetic or reconstructed precious and semi-precious stones (CN code 7103 as established by Regulation (EEC) No 2658/87) unless they have been treated with lead or its compounds or mixtures containing these substances; (d) enamels, defined as vitrifiable mixtures resulting from the fusion, vitrification or sintering of mineral melted at a temperature of at least 500 °C; (e) keys and locks, including padlocks; (f) musical instruments; (g) articles and parts of articles comprising brass alloys, if the concentration of lead (expressed as metal) in the brass alloy does not exceed 0,5 % by weight; (h) the tips of writing instruments; (i) religious articles; (j) portable zinc-carbon batteries and button cell batteries; (k) articles within the scope of: (i) Directive 94/62/EC; (ii) Regulation (EC) No 1935/2004; (iii) Directive 2009/48/EC of the European Parliament and of the Council ; (iv) Directive 2011/65/EU of the European Parliament and of the Council 9. By 1 July 2019, the Commission shall re-evaluate paragraphs 7 and 8(e), (f), (i) and (j) of this entry in the light of new scientific information, including the availability of alternatives and the migration of lead from the articles referred to in paragraph 7, including the requirement on coating integrity, and, if appropriate, modify this entry accordingly. 10. By way of derogation paragraph 7 shall not apply to articles placed on the market for the first time before 1 June 2016. 11. Doing either of the following acts after 15 February 2023 in or within 100 metres of wetlands is prohibited: (a) discharging gunshot containing a concentration of lead (expressed as metal) equal to or greater than 1 % by weight; (b) carrying any such gunshot where this occurs while out wetland shooting or as part of going wetland shooting. For the purposes of the first subparagraph: (a) within 100 metres of wetlands means within 100 metres outward from any outer boundary point of a wetland; (b) wetland shooting means shooting in or within 100 metres of wetlands; (c) if a person is found carrying gunshot in or within 100 metres of wetlands while out shooting or as part of going shooting, the shooting concerned shall be presumed to be wetland shooting unless that person can demonstrate that it was some other type of shooting. The restriction laid down in the first subparagraph shall not apply in a Member State if that Member State notifies the Commission in accordance with paragraph 12 that it intends to make use of the option granted by that paragraph. 12. If at least 20 % in total of the territory, excluding the territorial waters, of a Member State are wetlands, that Member State may, in place of the restriction laid down in the first subparagraph of paragraph 11, prohibit the following acts throughout the whole of its territory from 15 February 2024: (a) the placing on the market of gunshot containing a concentration of lead (expressed as metal) equal to or greater than 1 % by weight; (b) the discharging of any such gunshot; (c) carrying any such gunshot while out shooting or as part of going shooting. Any Member State intending to make use of the option granted by the first subparagraph shall notify the Commission of this intention by 15 August 2021. The Member State shall communicate the text of the national measures adopted by it to the Commission without delay and in any event by 15 August 2023. The Commission shall make publicly available without delay any such notices of intention and texts of national measures received by it. 13. For the purposes of paragraphs 11 and 12: (a) wetlands means areas of marsh, fen, peatland or water, whether natural or artificial, permanent or temporary, with water that is static or flowing, fresh, brackish or salt, including areas of marine water the depth of which at low tide does not exceed 6 metres; (b) gunshot means pellets used or intended for use in a single charge or cartridge in a shotgun; (c) shotgun means a smooth-bore gun, excluding airguns; (d) shooting means any shooting with a shotgun; (e) carrying means any carrying on the person or carrying or transporting by any other means; (f) in determining whether a person found with gunshot is carrying gunshot as part of going shooting: (i) regard shall be had to all the circumstances of the case; (ii) the person found with the gunshot need not necessarily be the same person as the person shooting. 14. Member States may maintain national provisions for protection of the environment or human health in force on 15 February 2021 and restricting lead in gunshot more severely than provided for in paragraph 11. The Member State shall communicate the text of those national provisions to the Commission without delay. The Commission shall make publicly available without delay any such texts of national provisions received by it. |
Text from EUR-Lex, before and after
Previous version, in force 1 January 2021 02006R1907-20210101 → this version, in force 4 January 2021 02006R1907-20210215
compared line by line: this provision is too large to compare word by word, so a marked line is a line that changed somewhere
ANNEX XVII
RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, MIXTURES AND ARTICLES
For substances which have been incorporated in this Annex as a consequence of restrictions adopted in the framework of Directive 76/769/EEC (Entries 1 to 58), the restrictions shall not apply to storage, keeping, treatment, filling into containers, or transfer from one container to another of these substances for export, unless the manufacture of the substances is prohibited.
… 18 unchanged lines …
Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).
Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (OJ L 79, 19.3.2008, p. 1).
Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, p. 1).
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).
Column 1
Designation of the substance, of the group of substances or of the mixture Column 2
Conditions of restriction
1. Polychlorinated terphenyls (PCTs) Shall not be placed on the market, or used:
as substances,
in mixtures, including waste oils, or in equipment, in concentrations greater than 50 mg/kg (0,005 % by weight).
2. Chloroethene (vinyl chloride)
CAS No 75-01-4
EC No 200-831-0 Shall not be used as propellant in aerosols for any use.
Aerosols dispensers containing the substance as propellant shall not be placed on the market.
3. Liquid substances or mixtures which are regarded as dangerous in accordance with Directive 1999/45/EC or are fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:
(a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;
(b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;
(c) hazard class 4.1;
(d) hazard class 5.1. 1. Shall not be used in:
ornamental articles intended to produce light or colour effects by means of different phases, for example in ornamental lamps and ashtrays,
tricks and jokes,
games for one or more participants, or any article intended to be used as such, even with ornamental aspects,
2. Articles not complying with paragraph 1 shall not be placed on the market.
3. Shall not be placed on the market if they contain a colouring agent, unless required for fiscal reasons, or perfume, or both, if they:
can be used as fuel in decorative oil lamps for supply to the general public, and,
present an aspiration hazard and are labelled with R65 or H304, can be used as fuel in decorative oil lamps for supply to the general public, and
present an aspiration hazard and are labelled with H304.
4. Decorative oil lamps for supply to the general public shall not be placed on the market unless they conform to the European Standard on Decorative oil lamps (EN 14059) adopted by the European Committee for Standardisation (CEN).
5. Without prejudice to the implementation of other Community provisions relating to the classification, packaging and labelling of dangerous substances and mixtures, suppliers shall ensure, before the placing on the market, that the following requirements are met:
(a) lamp oils, labelled with R65 or H304, intended for supply to the general public are visibly, legibly and indelibly marked as follows: Keep lamps filled with this liquid out of the reach of children; and, by 1 December 2010, Just a sip of lamp oil — or even sucking the wick of lamps — may lead to life-threatening lung damage;
(b) grill lighter fluids, labelled with R65 or H304, intended for supply to the general public are legibly and indelibly marked by 1 December 2010 as follows: Just a sip of grill lighter may lead to life threatening lung damage;
(c) lamp oils and grill lighters, labelled with R65 or H304, intended for supply to the general public are packaged in black opaque containers not exceeding 1 litre by 1 December 2010. 5. Without prejudice to the implementation of other Union provisions relating to the classification, labelling and packaging of substances and mixtures, suppliers shall ensure, before the placing on the market, that the following requirements are met:
(a) lamp oils, labelled with H304, intended for supply to the general public are visibly, legibly and indelibly marked as follows: Keep lamps filled with this liquid out of the reach of children; and, by 1 December 2010, Just a sip of lamp oil – or even sucking the wick of lamps – may lead to life-threatening lung damage;
(b) grill lighter fluids, labelled with H304, intended for supply to the general public are legibly and indelibly marked by 1 December 2010 as follows: Just a sip of grill lighter fluid may lead to life threatening lung damage;
(c) lamps oils and grill lighters, labelled with H304, intended for supply to the general public are packaged in black opaque containers not exceeding 1 litre by 1 December 2010.
6. No later than 1 June 2014, the Commission shall request the European Chemicals Agency to prepare a dossier, in accordance with Article 69 of the present Regulation with a view to ban, if appropriate, grill lighter fluids and fuel for decorative lamps, labelled R65 or H304, intended for supply to the general public.
7. Natural or legal persons placing on the market for the first time lamp oils and grill lighter fluids, labelled with R65 or H304, shall by 1 December 2011, and annually thereafter, provide data on alternatives to lamp oils and grill lighter fluids labelled R65 or H304 to the competent authority in the Member State concerned. Member States shall make those data available to the Commission.
4. Tris (2,3 dibromopropyl) phosphate
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mineral oil products intended for use as fuel in mobile or fixed combustion plants,
fuels sold in closed systems (e.g. liquid gas bottles);
(d) artists’ paints covered by Regulation (EC) No 1272/2008;
(e) the substances listed in Appendix 11, column 1, for the applications or uses listed in Appendix 11, column 2. Where a date is specified in column 2 of Appendix 11, the derogation shall apply until the said date. (e) the substances listed in Appendix 11, column 1, for the applications or uses listed in Appendix 11, column 2. Where a date is specified in column 2 of Appendix 11, the derogation shall apply until the said date;
(f) devices covered by Regulation (EU) 2017/745.
31. (a) Creosote; wash oil
CAS No 8001-58-9
EC No 232-287-5
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(iv) Directive 2011/65/EU of the European Parliament and of the Council
9. By 1 July 2019, the Commission shall re-evaluate paragraphs 7 and 8(e), (f), (i) and (j) of this entry in the light of new scientific information, including the availability of alternatives and the migration of lead from the articles referred to in paragraph 7, including the requirement on coating integrity, and, if appropriate, modify this entry accordingly.
10. By way of derogation paragraph 7 shall not apply to articles placed on the market for the first time before 1 June 2016.
11. Doing either of the following acts after 15 February 2023 in or within 100 metres of wetlands is prohibited:
(a) discharging gunshot containing a concentration of lead (expressed as metal) equal to or greater than 1 % by weight;
(b) carrying any such gunshot where this occurs while out wetland shooting or as part of going wetland shooting.
For the purposes of the first subparagraph:
(a) within 100 metres of wetlands means within 100 metres outward from any outer boundary point of a wetland;
(b) wetland shooting means shooting in or within 100 metres of wetlands;
(c) if a person is found carrying gunshot in or within 100 metres of wetlands while out shooting or as part of going shooting, the shooting concerned shall be presumed to be wetland shooting unless that person can demonstrate that it was some other type of shooting.
The restriction laid down in the first subparagraph shall not apply in a Member State if that Member State notifies the Commission in accordance with paragraph 12 that it intends to make use of the option granted by that paragraph.
12. If at least 20 % in total of the territory, excluding the territorial waters, of a Member State are wetlands, that Member State may, in place of the restriction laid down in the first subparagraph of paragraph 11, prohibit the following acts throughout the whole of its territory from 15 February 2024:
(a) the placing on the market of gunshot containing a concentration of lead (expressed as metal) equal to or greater than 1 % by weight;
(b) the discharging of any such gunshot;
(c) carrying any such gunshot while out shooting or as part of going shooting.
Any Member State intending to make use of the option granted by the first subparagraph shall notify the Commission of this intention by 15 August 2021. The Member State shall communicate the text of the national measures adopted by it to the Commission without delay and in any event by 15 August 2023. The Commission shall make publicly available without delay any such notices of intention and texts of national measures received by it.
13. For the purposes of paragraphs 11 and 12:
(a) wetlands means areas of marsh, fen, peatland or water, whether natural or artificial, permanent or temporary, with water that is static or flowing, fresh, brackish or salt, including areas of marine water the depth of which at low tide does not exceed 6 metres;
(b) gunshot means pellets used or intended for use in a single charge or cartridge in a shotgun;
(c) shotgun means a smooth-bore gun, excluding airguns;
(d) shooting means any shooting with a shotgun;
(e) carrying means any carrying on the person or carrying or transporting by any other means;
(f) in determining whether a person found with gunshot is carrying gunshot as part of going shooting:
(i) regard shall be had to all the circumstances of the case;
(ii) the person found with the gunshot need not necessarily be the same person as the person shooting.
14. Member States may maintain national provisions for protection of the environment or human health in force on 15 February 2021 and restricting lead in gunshot more severely than provided for in paragraph 11.
The Member State shall communicate the text of those national provisions to the Commission without delay. The Commission shall make publicly available without delay any such texts of national provisions received by it.
64. 1,4-dichlorobenzene
CAS No 106-46-7
EC No 203-400-5 Shall not be placed on the market or used, as a substance or as a constituent of mixtures in a concentration equal to or greater than 1 % by weight, where the substance or the mixture is placed on the market for use or used as an air freshener or deodoriser in toilets, homes, offices or other indoor public areas.
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(c) national exposure limits for diisocyanates, if there are any;
(d) information about enforcement activities related to this restriction.
10. This restriction shall apply without prejudice to other Union legislation on the protection of safety and health of workers at the workplace.
75.
Substances falling within one or more of the following points:
(a) substances classified as any of the following in Part 3 of Annex VI to Regulation (EC) No 1272/2008:
carcinogen category 1A, 1B or 2, or germ cell mutagen category 1A, 1B or 2, but excluding any such substances classified due to effects only following exposure by inhalation
reproductive toxicant category 1A, 1B or 2 but excluding any such substances classified due to effects only following exposure by inhalation
skin sensitiser category 1, 1A or 1B
skin corrosive category 1, 1A, 1B or 1C or skin irritant category 2
serious eye damage category 1 or eye irritant category 2
(b) substances listed in Annex II to Regulation (EC) No 1223/2009 of the European Parliament and of the Council
(c) substances listed in Annex IV to Regulation (EC) No 1223/2009 for which a condition is specified in at least one of the columns g, h and i of the table in that Annex
(d) substances listed in Appendix 13 to this Annex.
The ancillary requirements in paragraphs 7 and 8 of column 2 of this entry apply to all mixtures for use for tattooing purposes, whether or not they contain a substance falling within points (a) to (d) of this column of this entry. 1. Shall not be placed on the market in mixtures for use for tattooing purposes, and mixtures containing any such substances shall not be used for tattooing purposes, after 4 January 2022 if the substance or substances in question is or are present in the following circumstances:
(a) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as carcinogen category 1A, 1B or 2, or germ cell mutagen category 1A, 1B or 2, the substance is present in the mixture in a concentration equal to or greater than 0,00005 % by weight;
(b) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as reproductive toxicant category 1A, 1B or 2, the substance is present in the mixture in a concentration equal to or greater than 0,001 % by weight;
(c) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as skin sensitiser category 1, 1A or 1B, the substance is present in the mixture in a concentration equal to or greater than 0,001 % by weight;
(d) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as skin corrosive category 1, 1A, 1B or 1C or skin irritant category 2, or as serious eye damage category 1 or eye irritant category 2, the substance is present in the mixture in a concentration equal to or greater than:
(i) 0,1 % by weight, if the substance is used solely as a pH regulator;
(ii) 0,01 % by weight, in all other cases;
(e) in the case of a substance listed in Annex II to Regulation (EC) No 1223/2009
, the substance is present in the mixture in a concentration equal to or greater than 0,00005 % by weight;
(f) in the case of a substance for which a condition of one or more of the following kinds is specified in column g (Product type, Body parts) of the table in Annex IV to Regulation (EC) No 1223/2009, the substance is present in the mixture in a concentration equal to or greater than 0,00005 % by weight:
(i) Rinse-off products;
(ii) Not to be used in products applied on mucous membranes;
(iii) Not to be used in eye products;
(g) in the case of a substance for which a condition is specified in column h (Maximum concentration in ready for use preparation) or column i (Other) of the table in Annex IV to Regulation (EC) No 1223/2009, the substance is present in the mixture in a concentration, or in some other way, that does not accord with the condition specified in that column;
(h) in the case of a substance listed in Appendix 13 to this Annex, the substance is present in the mixture in a concentration equal to or greater than the concentration limit specified for that substance in that Appendix.
2. For the purposes of this entry use of a mixture for tattooing purposes means injection or introduction of the mixture into a person’s skin, mucous membrane or eyeball, by any process or procedure (including procedures commonly referred to as permanent make-up, cosmetic tattooing, micro-blading and micro-pigmentation), with the aim of making a mark or design on his or her body.
3. If a substance not listed in Appendix 13 falls within more than one of points (a) to (g) of paragraph 1, the strictest concentration limit laid down in the points in question shall apply to that substance. If a substance listed in Appendix 13 also falls within one or more of points (a) to (g) of paragraph 1, the concentration limit laid down in point (h) of paragraph 1 shall apply to that substance.
4. By way of derogation, paragraph 1 shall not apply to the following substances until 4 January 2023:
(a) Pigment Blue 15:3 (CI 74160, EC No 205-685-1, CAS No 147-14-8);
(b) Pigment Green 7 (CI 74260, EC No 215-524-7, CAS No 1328-53-6).
5. If Part 3 of Annex VI to Regulation (EC) No 1272/2008 is amended after 4 January 2021 to classify or re-classify a substance such that the substance then becomes caught by point (a), (b), (c) or (d) of paragraph 1 of this entry, or such that it then falls within a different one of those points from the one within which it fell previously, and the date of application of that new or revised classification is after the date referred to in paragraph 1 or, as the case may be, paragraph 4 of this entry, that amendment shall, for the purposes of applying this entry to that substance, be treated as taking effect on the date of application of that new or revised classification.
6. If Annex II or Annex IV to Regulation (EC) No 1223/2009 is amended after 4 January 2021 to list or change the listing of a substance such that the substance then becomes caught by point (e), (f) or (g) of paragraph 1 of this entry, or such that it then falls within a different one of those points from the one within which it fell previously, and the amendment takes effect after the date referred to in paragraph 1 or, as the case may be, paragraph 4 of this entry, that amendment shall, for the purposes of applying this entry to that substance, be treated as taking effect from the date falling 18 months after entry into force of the act by which that amendment was made.
7. Suppliers placing a mixture on the market for use for tattooing purposes shall ensure that, after 4 January 2022, the mixture is marked with the following information:
(a) the statement Mixture for use in tattoos or permanent make-up;
(b) a reference number to uniquely identify the batch;
(c) the list of ingredients in accordance with the nomenclature established in the glossary of common ingredient names pursuant to Article 33 of Regulation (EC) No 1223/2009, or in the absence of a common ingredient name, the IUPAC name. In the absence of a common ingredient name or IUPAC name, the CAS and EC number. Ingredients shall be listed in descending order by weight or volume of the ingredients at the time of formulation. Ingredient means any substance added during the process of formulation and present in the mixture for use for tattooing purposes. Impurities shall not be regarded as ingredients. If the name of a substance, used as ingredient within the meaning of this entry, is already required to be stated on the label in accordance with Regulation (EC) No 1272/2008, that ingredient does not need to be marked in accordance with this Regulation;
(d) the additional statement pH regulator for substances falling under point (d)(i) of paragraph 1;
(e) the statement "Contains nickel. Can cause allergic reactions." if the mixture contains nickel below the concentration limit specified in Appendix 13;
(f) the statement "Contains chromium (VI). Can cause allergic reactions." if the mixture contains chromium (VI) below the concentration limit specified in Appendix 13;
(g) safety instructions for use insofar as they are not already required to be stated on the label by Regulation (EC) No 1272/2008.
The information shall be clearly visible, easily legible and marked in a way that is indelible.
The information shall be written in the official language(s) of the Member State(s) where the mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise.
Where necessary because of the size of the package, the information listed in the first subparagraph, except for point (a), shall be included instead in the instructions for use.
Before using a mixture for tattooing purposes, the person using the mixture shall provide the person undergoing the procedure with the information marked on the package or included in the instructions for use pursuant to this paragraph.
8. Mixtures that do not contain the statement Mixture for use in tattoos or permanent make-up shall not be used for tattooing purposes.
9. This entry does not apply to substances that are gases at temperature of 20 °C and pressure of 101,3 kPa, or generate a vapour pressure of more than 300 kPa at temperature of 50 °C, with the exception of formaldehyde (CAS No 50-00-0, EC No 200-001-8).
10. This entry does not apply to the placing on the market of a mixture for use for tattooing purposes, or to the use of a mixture for tattooing purposes, when placed on the market exclusively as a medical device or an accessory to a medical device, within the meaning of Regulation (EU) 2017/745, or when used exclusively as a medical device or an accessory to a medical device, within the same meaning. Where the placing on the market or use may not be exclusively as a medical device or an accessory to a medical device, the requirements of Regulation (EU) 2017/745 and of this Regulation shall apply cumulatively.
Appendices 1 to 6
FOREWORD
Explanations of column headings
… 39 unchanged lines …
Note R:
The classification as a carcinogen need not apply to fibres with a length weighted geometric mean diameter, less two standard errors, greater than 6μm.
Appendix 1
Entry 28 — Carcinogens: category 1A (Table 3.1)/category 1 (Table 3.2) Entry 28 – Carcinogens: Category 1A
Substances Index No EC No CAS No Notes
Chromium (VI) trioxide 024-001-00-0 215-607-8 1333-82-0 E
Zinc chromates including zinc potassium chromate 024-007-00-3 Nickel monoxide; [1] 028-003-00-2 215-215-7 [1] 1313-99-1 [1] Nickel oxide; [2] 234-323-5 [2] 11099-02-8 [2]
… 400 unchanged lines …
77536-66-4
77536-68-6
77536-67-5 Appendix 2
Entry 28 — Carcinogens: category 1B (Table 3.1)/category 2 (Table 3.2) Entry 28 – Carcinogens: Category 1 B
Substances Index No EC No CAS No Notes
Beryllium 004-001-00-7 231-150-7 7440-41-7 Beryllium compounds with the exception of aluminium beryllium silicates 004-002-00-2 Beryllium oxide 004-003-00-8 215-133-1 1304-56-9 E
Sulfallate (ISO); 2-chlorallyl diethyldithiocarbamate 006-038-00-4 202-388-9 95-06-7 Dimethylcarbamoyl chloride 006-041-00-0 201-208-6 79-44-7 Diazomethane 006-068-00-8 206-382-7 334-88-3 O-isobutyl-N-ethoxy carbonylthiocarbamate 006-094-00-X 434-350-4 103122-66-3 O-hexyl-N-ethoxycarbonylthiocarbamate 006-102-00-1 432-750-3 — Hydrazine 007-008-00-3 206-114-9 302-01-2 E
… 1,262 unchanged lines …
Refractory Ceramic Fibres, Special Purpose Fibres, with the exception of those specified elsewhere in this Annex;
[Man-made vitreous (silicate) fibres with random orientation with alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+ MgO+BaO) content less or equal to 18 % by weight] 650-017-00-8 — — A, R
Appendix 3
Entry 29 — Mutagens: category 1A (Table 3.1)/category 1 (Table 3.2) Entry 29 – Germ cell mutagens: Category 1 A
Appendix 4
Entry 29 — Mutagens: category 1B (Table 3.1)/category 2 (Table 3.2) Entry 29 – Germ cell mutagens: Category 1 B
Substances Index No EC No CAS No Notes
O-isobutyl-N-ethoxy carbonylthiocarbamate 006-094-00-X 434-350-4 103122-66-3 O-hexyl-N-ethoxycarbonylthiocarbamate 006-102-00-1 432-750-3 — Hexamethylphosphoric triamide; hexamethylphosphoramide 015-106-00-2 211-653-8 680-31-9 Mixture of: dimethyl(2-(hydroxymethylcarbamoyl)ethyl)phosphonate;
Diethyl(2-(hydroxymethylcarbamoyl)ethyl)phosphonate;
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Aromatic hydrocarbons, C8-10;
Low boiling point naphtha - unspecified 649-403-00-9 292-695-4 90989-39-2 P
Appendix 5
Entry 30 — Toxic to reproduction: category 1A (Table 3.1)/category 1 (Table 3.2) Entry 30 – Reproductive toxicants: Category 1 A
Substances Index No EC No CAS No Notes
Carbon monoxide 006-001-00-2 211-128-3 630-08-0 Lead hexafluorosilicate 009-014-00-1 247-278-1 25808-74-6 Slimes and sludges, copper electrolyte refining, decopperised 028-015-00-8 305-433-1 94551-87-8 Silicic acid, lead nickel salt 028-050-00-9 — 68130-19-8 Lead compounds with the exception of those specified elsewhere in this Annex 082-001-00-6 A, E
Lead alkyls 082-002-00-1 A, E
Lead azide 082-003-00-7 236-542-1 13424-46-9 Lead chromate 082-004-00-2 231-846-0 7758-97-6 Lead di(acetate) 082-005-00-8 206-104-4 301-04-2 Trilead bis(orthophosphate) 082-006-00-3 231-205-5 7446-27-7 Lead acetate 082-007-00-9 215-630-3 1335-32-6 Lead(II) methanesulphonate 082-008-00-4 401-750-5 17570-76-2 C.I. Pigment Yellow 34;
(This substance is identified in the Colour Index by Colour Index Constitution No C.I. 77603.) 082-009-00-X 215-693-7 1344-37-2 C.I. Pigment Red 104;
(This substance is identified in the Colour Index by Colour Index Constitution No C.I. 77605.) 082-010-00-5 235-759-9 12656-85-8 Lead hydrogen arsenate 082-011-00-0 232-064-2 7784-40-9 Lead powder;
[particle diameter < 1 mm] 082-013-00-1 231-100-4 7439-92-1 Lead massive:
[particle diameter ≥ 1 mm] 082-014-00-7 231-100-4 7439-92-1 1,2-Dibromo-3-chloropropane 602-021-00-6 202-479-3 96-12-8 2-bromopropane 602-085-00-5 200-855-1 75-26-3 E
Warfarin (ISO);
4-hydroxy-3-(3-oxo-1- phenylbutyl)-2H-chromen-2-one; [1]
(S)-4-hydroxy-3-(3-oxo- 1-phenylbutyl)-2-benzopyrone; [2]
(R)-4-hydroxy-3-(3-oxo- 1-phenylbutyl)-2-benzopyrone [3] 607-056-00-0 201-377-6 [1]
226-907-3 [2]
226-908-9 [3] 81-81-2 [1]
5543-57-7 [2]
5543-58-8 [3] Brodifacoum (ISO);
4-hydroxy-3-(3-(4′-bromo-4-biphenylyl)-1,2,3,4-tetrahydro-1-naphthyl)coumarin 607-172-00-1 259-980-5 56073-10-0 Lead 2,4,6-trinitroresorcinoxide, lead styphnate 609-019-00-4 239-290-0 15245-44-0 Appendix 6
Entry 30 — Toxic to reproduction: category 1B (Table 3.1)/category 2 (Table 3.2) Entry 30 – Reproductive toxicants: Category 1 B
Substances Index No EC No CAS No Notes
Dibutyltin hydrogen borate 005-006-00-7 401-040-5 75113-37-0 Boric acid; [1] 005-007-00-2 233-139-2 [1] 10043-35-3 [1] Boric acid, crude natural, containing not more than 85 % of H3BO3 calculated on the dry weight; [2] 234-343-4 [2] 11113-50-1 [2]
Diboron trioxide;
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Entry 43 — Azocolourants — List of testing methods
List of testing methods
European standardisation organisation Reference and title of the harmonised standard Reference of the superseded standard
CEN EN ISO 17234-1:2010
Leather — Chemical tests for the determination of certain azo colorants in dyed leathers — Part 1: Determination of certain aromatic amines derived from azo colorants CEN ISO/TS 17234:2003 CEN EN ISO 17234-1:2015
Leather – Chemical tests for the determination of certain azo colorants in dyed leathers – Part 1: Determination of certain aromatic amines derived from azo colorants EN ISO 17234-1:2010
CEN EN ISO 17234-2:2011
Leather — Chemical tests for the determination of certain azo colorants in dyed leathers — Part 2: Determination of 4-aminoazobenzene CEN ISO/TS 17234:2003
CEN EN 14362-1:2012
Textiles — Methods for determination of certain aromatic amines derived from azo colorants — Part 1: Detection of the use of certain azo colorants accessible with and without extracting the fibres EN 14362-1:2003
EN 14362-2:2003
CEN EN 14362-3:2012
Textiles — Methods for determination of certain aromatic amines derived from azo colorants — Part 3: Detection of the use of certain azo colorants, which may release 4-aminoazobenzene Appendix 11 Leather – Chemical tests for the determination of certain azo colorants in dyed leathers – Part 2: Determination of 4-aminoazobenzene CEN ISO/TS 17234:2003
CEN EN ISO 14362-1:2017
Textiles – Methods for determination of certain aromatic amines derived from azo colorants – Part 1: Detection of the use of certain azo colorants accessible with and without extracting the fibres EN 14362-1:2012
CEN EN ISO 14362-3:2017
Textiles – Methods for determination of certain aromatic amines derived from azo colorants – Part 3: Detection of the use of certain azo colorants, which may release 4-aminoazobenzene EN 14362-3:2012
Appendix 11
Entries 28 to 30 — Derogations for specific substances
OJ L 104, 8.4.2004, p. 1.
Substances Derogations
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4-methoxy-m-phenylene diammonium sulphate; 2,4-diaminoanisole sulphate 612-200-00-0 39156-41-7 254-323-9 30 mg/kg
2,4,5-trimethylaniline hydrochloride 612-197-00-6 21436-97-5 — 30 mg/kg
Quinoline 613-281-00-5 91-22-5 202-051-6 50 mg/kgAppendix 13
Entry 75- List of substances with specific concentration limits:
Soluble. ‡Chromium VI.
Substance name EC No CAS No Concentration limit (by weight)
Mercury 231-106-7 7439-97-6 0,00005 %
Nickel 231-111-4 7440-02-0 0,0005 %
Organometallic tin 231-141-8 7440-31-5 0,00005 %
Antimony 231-146-5 7440-36-0 0,00005 %
Arsenic 231-148-6 7440-38-2 0,00005 %
Barium
231-149-1 7440-39-3 0,05 %
Cadmium 231-152-8 7440-43-9 0,00005 %
Chromium‡ 231-157-5 7440-47-3 0,00005 %
Cobalt 231-158-0 7440-48-4 0,00005 %
Copper
231-159-6 7440-50-8 0,025 %
Zinc
231-175-3 7440-66-6 0,2 %
Lead 231-100-4 7439-92-1 0,00007 %
Selenium 231-957-4 7782-49-2 0,0002 %
Benzo[a]pyrene 200-028-5 50-32-8, 63466-71-7 0,0000005 %
Polycyclic-aromatic Hydrocarbons (PAH), classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as carcinogen or germ cell mutagen category 1A, 1B or 2 0,00005 % (individual concentrations)
Methanol 200-659-6 67-56-1 11 %
o-Anisidine
201-963-1 90-04-0 0,0005 %
o-toluidine
202-429-0 95-53-4 0,0005 %
3,3'-dichlorobenzidine
202-109-0 91-94-1 0,0005 %
4-methyl-m- phenylenediamine
202-453-1 95-80-7 0,0005 %
4-chloroaniline
203-401-0 106-47-8 0,0005 %
5-nitro-o-toluidine
202-765-8 99-55-8 0,0005 %
3,3'-dimethoxybenzidine
204-355-4 119-90-4 0,0005 %
4,4'-bi-o-toluidine
204-358-0 119-93-7 0,0005 %
4,4'-Thiodianiline
205-370-9 139-65-1 0,0005 %
4-chloro-o-toluidine
202-441-6 95-69-2 0,0005 %
2-naphthylamine
202-080-4 91-59-8 0,0005 %
Aniline
200-539-3 62-53-3 0,0005 %
Benzidine
202-199-1 92-87-5 0,0005 %
p-toluidine
203-403-1 106-49-0 0,0005 %
2-methyl-p-phenylenediamine
202-442-1 95-70-5 0,0005 %
Biphenyl-4-ylamine
202-177-1 92-67-1 0,0005 %
4-o-tolylazo-o-toluidine
202-591-2 97-56-3 0,0005 %
4-methoxy-m- phenylenediamine
210-406-1 615-05-4 0,0005 %
4,4'-methylenedianiline
202-974-4 101-77-9 0,0005 %
4,4'-methylenedi-o-toluidine
212-658-8 838-88-0 0,0005 %
6-methoxy-m-toluidine
204-419-1 120-71-8 0,0005 %
4,4'- methylene-bis-[2-chloro aniline]
202-918-9 101-14-4 0,0005 %
4,4'-oxydianiline
202-977-0 101-80-4 0,0005 %
2,4,5-trimethylaniline
205-282-0 137-17-7 0,0005 %
4-Aminoazobenzene
200-453-6 60-09-3 0,0005 %
p-Phenylenediamine
203-404-7 106-50-3 0,0005 %
Sulphanilic acid
204-482-5 121-57-3 0,0005 %
4-amino-3-fluorophenol
402-230-0 399-95-1 0,0005 %
2,6-xylidine 201-758-7 87-62-7 0,0005 %
6-amino-2-ethoxynaphthaline 293733-21-8 0,0005 %
2,4-xylidine 202-440-0 95-68-1 0,0005 %
Pigment Red 7 (PR7)/CI 12420 229-315-3 6471-51-8 0,1 %
Pigment Red 9(PR9)/CI 12460 229-104-6 6410-38-4 0,1 %
Pigment Red 15 (PR15)/CI 12465 229-105-1 6410-39-5 0,1 %
Pigment Red 210(PR210)/CI 12477 612-766-9 61932-63-6 0,1 %
Pigment Orange 74 (PO74) 85776-14-3 0,1 %
Pigment Yellow 65 (PY65)/CI 11740 229-419-9 6528-34-3 0,1 %
Pigment Yellow 74 (PY74)/CI 11741 228-768-4 6358-31-2 0,1 %
Pigment Red 12 (PR12)/CI 12385 229-102-5 6410-32-8 0,1 %
Pigment Red 14 (PR14)/CI 12380 229-314-8 6471-50-7 0,1 %
Pigment Red 17 (PR17)/CI 12390 229-681-4 6655-84-1 0,1 %
Pigment Red 112 (PR112)/CI 12370 229-440-3 6535-46-2 0,1 %
Pigment Yellow 14 (PY14)/CI 21095 226-789-3 5468-75-7 0,1 %
Pigment Yellow 55 (PY55)/CI 21096 226-789-3 6358-37-8 0,1 %
Pigment Red 2 (PR2)/CI 12310 227-930-1 6041-94-7 0,1 %
Pigment Red 22 (PR22)/CI 12315 229-245-3 6448-95-9 0,1 %
Pigment Red 146 (PR146)/CI 12485 226-103-2 5280-68-2 0,1 %
Pigment Red 269 (PR269)/CI 12466 268-028-8 67990-05-0 0,1 %
Pigment Orange16 (PO16)/CI 21160 229-388-1 6505-28-8 0,1 %
Pigment Yellow 1 (PY1)/CI 11680 219-730-8 2512-29-0 0,1 %
Pigment Yellow 12 (PY12)/CI 21090 228-787-8 6358-85-6 0,1 %
Pigment Yellow 87 (PY87)/CI 21107:1 239-160-3 15110-84-6,
14110-84-6 0,1 %
Pigment Yellow 97 (PY97)/CI 11767 235-427-3 12225-18-2 0,1 %
Pigment Orange 13 (PO13)/CI 21110 222-530-3 3520-72-7 0,1 %
Pigment Orange 34 (PO34)/CI 21115 239-898-6 15793-73-4 0,1 %
Pigment Yellow 83 (PY83)/CI 21108 226-939-8 5567-15-7 0,1 %
Solvent Red 1 (SR1)/CI 12150 214-968-9 1229-55-6 0,1 %
Acid Orange 24 (AO24)/CI 20170 215-296-9 1320-07-6 0,1 %
Solvent Red 23 (SR23)/CI 26100 201-638-4 85-86-9 0,1 %
Acid Red 73 (AR73)/CI 27290 226-502-1 5413-75-2 0,1 %
Disperse Yellow 3/CI 11855 220-600-8 2832-40-8 0,1 %
Acid Green 16 603-214-8 12768-78-4 0,1 %
Acid Red 26 223-178-3 3761-53-3 0,1 %
Acid Violet 17 223-942-6 4129-84-4 0,1 %
Basic Red 1 213-584-9 989-38-8 0,1 %
Disperse Blue 106 602-285-2 12223-01-7 0,1 %
Disperse Blue 124 612-788-9 61951-51-7 0,1 %
Disperse Blue 35 602-260-6 12222-75-2 0,1 %
Disperse Orange 37 602-312-8 12223-33-5 0,1 %
Disperse Red 1 220-704-3 2872-52-8 0,1 %
Disperse Red 17 221-665-5 3179-89-3 0,1 %
Disperse Yellow 9 228-919-4 6373-73-5 0,1 %
Pigment Violet 3 603-635-7 1325-82-2 0,1 %
Pigment Violet 39 264-654-0 64070-98-0 0,1 %
Solvent Yellow 2 200-455-7 60-11-7 0,1 %
The full entry is committed at eu/32006R1907/CHANGELOG.md.