REACH – Substances of Very High Concern

How the legal obligations for SVHCs are applicable to consumer products.

European Registration, Evaluation, Authorisation and restriction of Chemicals (REACH) legislation came into force on 1st June 2007. It was adopted to improve the protection of human health and the environment from the risks posed by chemicals, and it is implemented by the European Chemicals Agency (ECHA).

In principle, REACH applies to all chemical substances – not only those utilised in industrial processes, but also in those used in everyday life (for example, in cleaning products and paints, as well as in ‘articles’). In this context, an ‘article’ is an object which during production is given a special shape, surface or design that determines its function to a greater degree than its chemical composition. Therefore, footwear, clothing, furniture, jewellery and toys are all examples of articles that need to comply with REACH.

What are SVHCs?

Substances of Very High Concern (SVHCs) fall under the ‘authorisation’ category of REACH, and this process aims to ensure that substances associated with health or environmental concerns are progressively replaced by less dangerous options. Substances with the following hazard properties may be identified as SVHCs:

• those meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction (CMR) categories 1A or 1B, in accordance with the Classification, Labelling and Packaging (CLP) Regulation
• substances which are persistent, bio-accumulative and toxic (‘PBT’) or very persistent and very bio-accumulative (‘vPvB’) according to REACH Annex XIII
• others on a case-by-case basis that cause an equivalent level of concern as CMR or PBT/vPvB substances.

Member states or ECHA can nominate a substance to be identified as an SVHC, which then has to be approved through a consultation process. There are currently 219 substances identified as SVHCs and included on the Candidate List (of substances to be assessed). The list is updated biannually, with new additions typically being added in January and July.

The intention to propose a substance for identification as an SVHC is published in the ‘Registry of Intentions’, before the proposal is submitted, to inform industry and other stakeholders in advance of the submission. After publication of the proposal, anyone can comment on it or provide further information during a 45-day public consultation. If no comments challenging the identification are received, the substance is included on the Candidate List. When comments are received that provide new information or challenge the basis for the identification as an SVHC, the Member State Committee (MSC) considers both the proposal and the comments to agree on the identification of the substance as an SVHC. If the committee does not reach a unanimous agreement, the matter is referred to the European Commission.

Legal obligations

Once a substance is identified as an SVHC and it has been included on the Candidate List of Substances for Authorisation, this will trigger certain legal obligations for the importers, producers and suppliers of an article that contains the substance.

Primary responsibility for compliance lies with the manufacturer or first importer into the European Union. However, retailers and distributors who are buying in the EU should check that their suppliers understand and have implemented their obligations with respect to SVHCs. Following the United Kingdom’s exit from the EU at the start of 2021, the UK enacted its own version of REACH regulations – ‘UK REACH’ – which currently mirrors the EU regulations. Suppliers into the UK will therefore be subject to the same obligations.

The inclusion of a substance on the Candidate List brings immediate obligations for suppliers of the substance, such as:

• supplying a safety data sheet
• communicating on safe use
• responding to consumer requests within 45 days and
• notifying ECHA – or the Health and Safety Executive (HSE) in the case of the UK – if the article they produce contains an SVHC in quantities above one tonne per producer/importer per year and if the substance is present in those articles above a concentration of 0.1 per cent (w/w).

The inclusion of a substance on the Candidate List does not constitute a ban on the substance in articles. However, if it is present at 0.1 per cent or above based on the total weight of the article, information should be placed into the supply chain about the presence of the chemical in the product. Since January 2021, companies also need to submit a notification to the Substances of Concern in articles and Products (SCIP) database, providing details of the product and the SVHC present. If one tonne per annum or more of the substance is brought into the EU by an individual company, a notification must be made to ECHA, which should be no later than six months after its inclusion on the Candidate List. The same obligations apply for substances being brought into the UK. However, in this case, the notification would be made to the HSE.

This process of notification allows ECHA to evaluate the potential risks which may be posed by each chemical on the list. Notification will not be required if the producer or importer of an article can exclude the exposure of humans and the environment to the substance during normal or reasonably foreseeable conditions of use of the article (including its disposal) or if the substance has already been registered by a manufacturer or importer in the EU for that specific use.

Consumers can request information on SVHC chemicals from the supplier or retailer, who are obliged to provide a response within 45 days. This requirement may raise some challenges for smaller retailers, whose retail staff may not be sufficiently trained to recognise REACH requests from customers.

Testing a product containing many different materials against the complete list of SVHCs would place a massive financial burden on the supply chain. Therefore, an approach which relies on risk assessment, screening tests and informed decisions about the potential for the presence of the substances in the materials used can reduce the amount of testing required to a manageable level.

The key points to consider when deciding if a material needs to be tested are: i) the information which can be provided by material suppliers, ii) the fact that identical materials used in different products only need to be tested once, iii) that an understanding of the materials used for each component can narrow down some of the testing required, iv) an identification of any treatments used to modify the properties – such as flame retardants and water-resistant coatings (some of the substances on the list are specialist chemicals which are only used for specific applications), and v) a calculation of how much of each material will be used – the larger the use, the greater the potential for exceeding the SVHC threshold.

Many organisations in the supply chain base their testing regimes on a REACH risk assessment to narrow the selection of testing required. The materials used in an article should be assessed to identify which SVHCs are relevant, and screening tests used to cover a number of SVHCs in one analysis. This is particularly useful for polymeric materials that may contain metal compounds as pigments or stabilisers. Using ‘Inductively Coupled Plasma Optical Emission Spectroscopy’ (ICP-OES) analysis, a total acid digestion of a material can be screened simultaneously for a number of metallic elements. Results from these tests can give confidence that the specific SVHCs are absent. Alternatively, they could prompt further investigation if concerns are indicated.

Testing strategies

The 0.1 per cent threshold for SVHCs is based on the weight of the entire article. From an analytical perspective, this is a high threshold considering that some of the restrictions of Annex XVII chemicals are many times lower (this will be explained further in the second article in this series). The substances on the list are relevant to a wide range of industries. Some of these are very specific, such as for the electronics or glass industries. The SVHCs below have been assessed by SATRA as relevant to leather and footwear products and table 1 summarises the groups of tests that may be carried out in a screening assessment for SVHCs.

Table 1: Relevant substances for leather and footwear materials
	Leathers	Textiles	Coated textiles	Plastics
Chlorinated paraffins	X		X
N-methyl-2-pyrrolidone	X
Azo dyes (table 2)	X*	X*
4-nonylphenol (and ethoxylated)	X	X
Disperse dyes (direct red 28 and direct black 38)	X*	X*
TCEP	X	X	X	X
PAHs (table 3)	X	X	X	X
VOCs (table 4)	X	X	X	X
Dimethylformamide			X
Phthalate plasticisers (table 5)			X	X
Total metals screening	X	X	X	X
*Dyed materials only

Short chain chlorinated paraffins may be present in leather or used as a flame retardant on textile materials, classified as ‘PBT’ and ‘vPvB’ and were added to the Candidate List in October 2008.

N-methyl-2-pyrrolidone can be present in leather, is toxic for reproduction and was added to the Candidate List in June 2011.

Azo colourants: nine dyestuff intermediates (see table 2) that may be present in dyed leathers and textiles, classified as carcinogenic and added to the Candidate List between December 2011 and 2012.

Table 2: REACH Candidate List aromatic amines potentially formed from azo colourants
Chemical	CAS number
4-aminobiphenolbiphenyl-4-ylamine	92-67-1
o-aminoazotoluene	97-56-3
4,4’-methylenedi-o-toluidine	838-88-0
p-cresidine	120-71-8
4,4’-oxydianiline	101-80-4
o-toluidine	95-53-4
4-methyl-m-phenylenediamine	95-80-7
o-anisidine	90-04-0
4-aminoazobenzene	60-09-3

4-nonylphenol (4-NP) and nonylphenol ethoxylates (NPEs): 4-NP is used as an auxiliary in the leather processing industry and can be present in paint or adhesives. NPEs can be used as wetting agents for textiles prior to dyeing and could also be used as finishing agents or in the coating of leather. 4-NP and NPEs are considered as ‘equivalent level of concern having probable serious effects to the environment’ and were added to the Candidate List between 2012 and 2013. Testing for 4-NP can also be used as a screening test for Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1 per cent w/w of 4-nonylphenol, branched and linear (4-NP), which was added to the Candidate List in July 2019.

Direct red 28 (disodium 3,3’-[[1,1’-biphenyl]-4,4’-diylbis (azo)] bis (4-aminonapthalene-1-sulphonate) and direct black 38 (disodium 4-amino-3-[[4’-[(2,4-diaminophenyl) azo][1,1’-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo) naphthalene-2, 7-disulphonate) are disperse dyes that could be used in textiles and leathers. They are classified as carcinogenic and were added to the Candidate List in December 2013.

Tris(2-chloroethyl)phosphate (TCEP) is mainly used as an additive plasticiser and viscosity regulator within the furniture and textile industries. Classified as toxic for reproduction, it was added to the Candidate List in January 2010.

Polycyclic aromatic hydrocarbons (PAHs) are impurities derived from coal or in several petroleum streams, and could affect rubbers, plastics and dyes. Tests for the nine PAH SVHCs (see table 3) can be done together, the most recent PAHs having been added in January 2019.

Table 3: REACH Candidate List polycyclic aromatic hydrocarbons
Chemical	CAS number
Anthracene	120-12-7
Benzo[def]chrysene (Benzo[a]pyrene)	50-32-8
Chrysene	218-01-9
Benz[a]anthracene	56-55-3
Benzo[ghi]perylene	191-24-2
Benzo[k]fluoranthene	207-08-9
Fluoranthene	206-44-0
Phenanthrene	85-01-8
Pyrene	129-00-0

There are eight volatile organic compounds (VOCs) that are often used as solvents in cleaning processes or plastic production, and are classified as carcinogenic or toxic for reproduction (see table 4). These SVHCs can be tested in a screening test using Gas Chromatography with Mass Spectrometry (GC-MS) headspace analysis and were added to the Candidate List between 2010 and 2011.

Table 4: REACH Candidate List VOCs that can be detected by GC-MS headspace
Chemical	CAS number
2-ethoxyethyl acetate	111-15-9
2,2’-dichloro-4,4’-methylenedianiline (MOCA)	101-14-4
Bis(2-methoxyethyl) ether	111-96-6
1,2-dichloroethane	107-06-2
Trichloroethylene	79-01-6
2-methoxyethanol	109-86-4
2-ethoxyethanol	110-80-5
1,2,3-trichloropropane	96-18-4

N,N-dimethylformamide (DMFa) is used in the production of acrylic fibres and plastics (polyurethanes), as well as in the manufacture of adhesives, synthetic leathers and surface coatings. It is classified as toxic for reproduction and was added to the Candidate List in December 2012.

Phthalate plasticisers: There are 15 plasticisers (see table 5) that could be present in flexible polymers – predominantly polyvinyl chloride (PVC) – that are toxic for reproduction and were added to the Candidate List between 2008 and 2020.

Table 5: REACH Candidate List phthalates
Phthalate	Acronym	CAS number
Bis (2-ethylhexyl) phthalate	DEHP	117-81-7
Dibutyl phthalate	DBP	84-74-2
Benzyl butyl phthalate	BBP	85-68-7
Di-isobutyl phthalate	DIBP	84-69-5
Di-isoheptyl phthalate	DIHP	71888-89-6
Bis(2-methoxyethyl) phthalate	DMEP	117-82-8
Di-n-hexyl phthalate	DnHP	84-75-3
Di-n-pentyl phthalate	DnPP	131-18-0
Di-isopentyl phthalate	DIPP	605-50-5
Dicyclohexyl phthalate	DCHP	84-61-7
1,2-benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters	DHNUP	68515-42-4
1,2-benzenedicarboxylic acid, dipentylester, branched and linear		84777-06-0
N-pentyl-isopentyl phthalate		776297-69-9
1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear		68515-50-4
Diisohexyl phthalate		71850-09-4

Metal-containing SVHCs – more than 60 of the SVHCs contain metal atoms and can be screened for by total metal content testing. Many of the substances containing metals are used as pigments, and are classified as carcinogenic, mutagenic or toxic for reproduction. For instance, potassium chromate is used in the tanning of leather and dyeing of textiles, and is classified as carcinogenic and mutagenic. Testing for the presence of potassium and chromium can rule out the presence of this SVHC above 0.1 per cent, if the levels are below a calculated value based on the molecular weight and formula of the substance.

In conclusion

Once a substance is identified as an SVHC and included on the Candidate List, certain obligations apply. When greater than 0.1 per cent of the substance is present based on the total weight of the article, information needs to be made available in the supply chain. If one tonne per annum or more of the substance is brought into the EU by a company, ECHA must be notified. For a specific product, SATRA can assess the materials present against the list of SVHCs and develop a realistic testing programme taking into account the legislative requirements, relevant substances and testing costs.

---