SGS: European Union to regulate 33 carcinogenic, mutagenic or reprotoxic (CMR) category 1A or 1B substances under new entry 72 to Annex XVII of REACH

The European Commission has published a guideline with methods to assist the industry to comply with CMRs under entry 72 to Annex XVII of REACH. The stricter limits apply for different concentration limits in other entries to Annex XVII of REACH or EU legislation.

(PRESS RELEASE) GENEVA, 28-Dec-2018 — /EuropaWire/ — On October 12, 2018, the European Union (EU) published Regulation (EU) 2018/1513 [1] to regulate 33 carcinogenic, mutagenic or reprotoxic (CMR) category 1A or 1B substances under new entry 72 to Annex XVII of REACH (Safeguard 148/18 [2]). The scope applies to the following:

(i) Clothing or related accessories
(ii) 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
(iii) Footwear

This new piece of legislation will become effective after November 1, 2020. The new law contains multiple derogations, including a less stringent limit of 300 mg/kg for formaldehyde in jackets, coats or upholstery during November 1, 2020 and November 1, 2023. After this period, the more stringent limit of 75mg/kg applies. This derogation was due to limited information on suitable alternatives and to allow economic operators to adapt to the restrictions.

Within a week of the publication of the new law, the European Commission (EC) published an explanatory guide [3] to clarify the scope of the new legislation and to provide a (non-exhaustive) list of examples that are considered or not considered to fall under the scope of restriction. While clothing or other related accessories (point (i)), and footwear (point (iii)) in the aforementioned scope are self-explanatory, the guideline provides a number of examples for point (ii) relating to ‘textiles other than clothing which come into contact with the human skin under normal or reasonably foreseeable condition of use to an extent similar to clothing’. These examples include:

Bath robes, bed linen, blankets
Cushion covers
Sleeping bags
Towels
Upholstery (fabric covering chairs, armchairs, and sofas etc.)

Toys such as plush toys can also be considered to fall under the scope as one may hug these for long periods.

According to the guideline, there are different concentration limits for these 33 new CMR substances in other entries of Annex XVII to REACH or other pieces of EU legislation. Where there are such differences, the stricter limits always apply. Examples of such differences are, inter alia, the limits on polycyclic aromatic hydrocarbons (PAHs) under entry 50 to Annex XVII of REACH and those in Directive 2009/48/EC, the Toy Safety Directive (TSD). It is also important to note that the TSD prohibits all CMR substances in toys.

The guideline provides a list of available methods in certain matrixes that can be used for the determination of the different CMR substances. It is interesting to note that the suggested method for benzene is for benzene emission (see item 17, Table 1). The guideline also suggests using the most effective method as some of the listed methods may require some adaptations.

Highlights of the CMRs and methods from the guideline are summarized in Table 1.

Item	CMR [CAS]	Requirement	Method
1	Formaldehyde [50-00-0]	≤ 300 mg/kg or ≤ 75 mg/kg**	– EN ISO 14184-1:2011 – ISO 17226-1:2008 as a possible alternative
2	Cadmium and its compounds* (expressed as Cd)	≤ 1 mg/kg each	EN 16711-2:2015
3	Arsenic compounds* (expressed as As)
4	Lead and its compounds* (expressed as Pb)
5	Chromium (VI) compounds* (expressed as Cr (VI))	≤ 1 mg/kg	– EN ISO 17075-1:2017 – EN ISO 17075-2:2017 – DIN 38405 – Oekotex ST 201 – M10ML102017
6	α, α, α, 4-tetrachlorotoluene [5216-25-1]	≤ 1 mg/kg each	DIN 54232:2010
7	α, α, α,-trichlorotoluene [98-07-7]
8	α-chlorotoluene [100-44-6]
9	1,2-benzenedicarboxylic acid; di-C₆–₈-brached alkyl esters C-7 rich [71888-89-6]	≤ 1000 mg/kg individually or in combination	EN ISO 14389:2014
10	Bis(2-methoxyethyl) phthalate [117-82-8]
11	Diisopentyl phthalate [605-50-5]
12	Di-n-pentyl phthalate (DPP) [131-18-0]
13	Di-n-hexyl phthalate (DnHP) [84-75-3]
14	N-methyl-2-pyrrolidone (NMP) [872-50-40]	≤ 3000 mg/kg each	CEN ISO/TS 16189:2013
15	N, N-dimethylacetamide (DMAC) [127-19-5]
16	N, N-dimethyl formamide (DMF) [68-12-2]
17	Benzene [71-43-2]	≤ 5 mg/kg (emission)	For example: VDA 278
18	Benz[a]anthracene [56-55-3]	≤ 1 mg/kg each	AFPS GS 2014
19	Benz[e]acephenanthrylene [205-99-2]
20	Benzo[a]pyrene [50-32-8]
21	Benzo[e]pyrene] [192-97-2]
22	Benzo[j]fluoranthene [205-82-3]
23	Benzo[k]fluoranthene [207-08-9]
24	Chrysene [218-01-9]
25	Dibenz[a,h]anthracene [53-70-3]
26	C.I Basic Violet 3 with ≥ 0.1% of Michler’s ketone [548-62-9]	≤ 50 mg/kg each	– EN ISO 16373-2:2014 – DIN 54231:2005
27	C.I. Disperse Blue 1 [2475-45-8]
28	C.I. Basic Red 9 [569-61-9]
29	4-chloro-o-toluidinium chloride [3165-93-3]	≤ 30 mg/kg each	EN ISO 14362:2017
30	2-Naphthylammonium acetate [553-00-4]
31	4-methoxy-m-phenylene diammonium sulphate [39156-41-7]
32	2,4,5-trimethylaniline hydrochloride [21436-97-5]
33	Quinoline [91-22-5]	≤ 50 mg/kg	MeOH or THF extraction, HPLC- DAD or HPLC- MS/MS
Listed under entries 28-30 to Appendices 1-6 in Annex XVII of REACH * 75 mg/kg limit applies from November 2, 2023

Table 1.

DEFINITIONS

Item	Abbreviation	Name
1	MeOH	Methanol
2	THF	Tetrahydrofuran
3	HPLC-DAD	High Performance Liquid Chromatography-Diode Array Detector
4	HPLC-MS/MS	High Performance Liquid Chromatography-Tandem Mass Spectrometry

Next step:

Stakeholders are advised to comply with the latest requirements for REACH for the EU market.

SGS will follow up and inform interested parties as developments on REACH regulation occur. Our expertise combined with consultancy services and experience in consumer product supply chains provides a central point of contact for global solutions. If you would like to learn more about how SGS can support your REACH compliance activities please visit www.sgs.com/reach.

For enquiries, please contact:

Hingwo Tsang
Global Information and Innovation Manager
t: +852 2774 7420

Stay on top of regulatory changes within your industry: subscribe to SafeGuardS!

Read more articles for the Consumer Goods and Retail industry!

_{© SGS Group Management SA – 2018 – All rights reserved – SGS is a registered trademark of SGS Group Management SA. This is a publication of SGS, except for 3rd parties’ contents submitted or licensed for use by SGS. SGS neither endorses nor disapproves said 3rd parties contents. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. It is strictly educational and does not replace any legal requirements or applicable regulations. It is not intended to constitute consulting or professional advice. The information contained herein is provided “as is” and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality. Do not quote or refer any information herein without SGS’s prior written consent.}

SOURCE: SGS SA