Formaldehyde (oplossing)

Toepasselijke REACH-regel: Beperkingen nr. 72 en nr. 75 en nr. 77

Opgeslagen juridische beperkingstekst (Engels)

Beperking nr. 72: 1. Shall not be placed on the market after 1 November 2020 in any of the following: (a) clothing or related accessories; (b) textiles other than clothing which, under normal or reasonably foreseeable conditions of use, come into contact with human skin to an extent similar to clothing; (c) footwear; if the clothing, related accessory, textile other than clothing or footwear is for use by consumers and the substance is present in a concentration, measured in homogeneous material, equal to or greater than that specified for that substance in Appendix 12. 2. By way of derogation, in relation to the placing on the market of formaldehyde [CAS No 50-00-0] in jackets, coats or upholstery, the relevant concentration for the purposes of paragraph 1 shall be 300 mg/kg during the period between 1 November 2020 and 1 November 2023 . The concentration specified in Appendix 12 shall apply thereafter. 3. Paragraph 1 shall not apply to: (a) clothing, related accessories or footwear, or parts of clothing, related accessories or footwear, made exclusively of natural leather, fur or hide; (b) non-textile fasteners and non-textile decorative attachments; (c) second-hand clothing, related accessories, textiles other than clothing or footwear (d) wall-to-wall carpets and textile floor coverings for indoor use, rugs and runners. 4. Paragraph 1 shall not apply to clothing, related accessories, textiles other than clothing, or footwear within the scope of Regulation (EU) 2016/425 of the European Parliament and of the Council (*) or Regulation (EU) 2017/745 of the European Parliament and of the Council (**). 5. Paragraph 1(b) shall not apply to disposable textiles. Disposable textiles means textiles that are designed to be used only once or for a limited time and are not intended for subsequent use for the same or a similar purpose. 6. Paragraphs 1 and 2 shall apply without prejudice to the application of any stricter restrictions set out in this Annex or in other applicable Union legislation. 7. The Commission shall review the exemption in paragraph 3(d) and, if appropriate, modify that point accordingly. (*) Regulation (EU) 2016/425 of the European Parliament and of the Council of of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC ( OJ L 81, 31.3.2016, p. 51 ). (**) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC ( OJ L 117, 5.5.2017, p. 1 ). Beperking nr. 75: 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. Beperking nr. 77: 1. Shall not be placed on the market in articles, after 6 August 2026 , if, under the test conditions specified in Appendix 14, the concentration of formaldehyde released from those articles exceeds: (a) 0,062 mg/m 3 for furniture and wood-based articles; (b) 0,080 mg/m 3 for articles other than furniture and wood-based articles. The first subparagraph shall not apply to: (a) articles in which formaldehyde or formaldehyde releasing substances are exclusively naturally present in the materials from which the articles are produced; (b) articles that are exclusively for outdoor use under foreseeable conditions; (c) articles in constructions, that are exclusively used outside the building shell and vapour barrier and that do not emit formaldehyde into indoor air; (d) articles exclusively for industrial or professional use unless formaldehyde released from them leads to exposure of the general public under foreseeable conditions of use; (e) articles for which the restriction laid down in entry 72 applies; (f) articles that are biocidal products within the scope of Regulation (EU) No 528/2012 of the European Parliament and of the Council ; (g) devices within the scope of Regulation (EU) 2017/745; (h) personal protective equipment within the scope of Regulation (EU) 2016/425; (i) articles intended to come into contact directly or indirectly with food within the scope of Regulation (EC) No 1935/2004; (j) second-hand articles. 2. Shall not be placed on the market in road vehicles after 6 August 2027 if, under the test conditions specified in Appendix 14, the concentration of formaldehyde in the interior of those vehicles exceeds 0,062 mg/m 3 . The first subparagraph shall not apply to: (a) road vehicles exclusively for industrial or professional use unless the concentration of formaldehyde in the interior of those vehicles leads to exposure of the general public under foreseeable conditions of use; (b) second-hand vehicles.

Bron: Annex XVII — specifieke beperking