Eight new substances added to the REACH Candidate List

Outlining the additions to the July 2021 publication.

The REACH Candidate List – also referred to as the ‘REACH Substances of Very High Concern’ (SVHCs) list – itemises 219 substances that may have serious effects on human health or the environment. These might be classified as i) persistent, bio-accumulative and toxic for the environment, ii) carcinogenic, iii) mutagenic or iv) toxic for reproduction. Candidate List substances are not restricted, but are in the process of being evaluated and could become authorised substances which are not able to be used in the European Union (EU), unless a specific exemption has been granted. One aim of creating the SVHC list was to ensure that these substances would no longer be used in industry and that their presence in articles would be progressively replaced with suitable less hazardous substitutes.

Once a substance has been added to the Candidate List, there is a six-month window, after which time the European Chemicals Agency (ECHA) must be notified if the substance is present in an article above 0.1 per cent, and if one tonne or more of the substance is being brought into the EU per annum across all products by an individual company. These obligations are largely focused upon the sharing of information.

ECHA must be notified if one tonne or more of the substance is being brought into the EU per annum across all products by a company and if it is present in an article above 0.1 per cent

In the July 2021 revision to the SVHC list, there were eight new additions. These are shown in table 1.

Table 1: Additional SVHCs in the July 2021 revision
Substance	CAS number	Reason for inclusion	Relevant materials or uses
2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers	–	Toxic for reproduction	Cleaning agents, biocidal products, cosmetics, washing and cleaning products, scented articles, polishes and wax blends
Orthoboric acid, sodium salt	13840-56-7	Toxic for reproduction	Documented uses include as a solvent and corrosion inhibitor
2,2-dimethylpropan-1-ol, tribromo derivative (TBNPA) 3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA) 2,2-bis(bromomethyl)propane1,3-diol (BMP) 2,3-dibromo-1-propanol (2,3-DBPA)	36483-37-5 1522-92-5 3296-90-0 96-13-9	Carcinogenic	TBNPA: polymer processing BMP: industrial use as flame retardant intermediate and in one-component foams DBPA: chemical intermediate
Glutaraldehyde	111-30-8	Respiratory sensitising properties	Leather tanning, biocides, cosmetics, cleaning agents
Medium-chain chlorinated paraffins (MCCP) and other substances consisting of more than or equal to 80 per cent linear chloroalkanes with carbon chain lengths within the range from C14 to C17	–	Persistent, bio-accumulative and toxic	Polyvinyl chloride (PVC), rubbers, paints, adhesives, sealants, textiles. Leather fat liquors and flame retardant treatments
Phenol, alkylation products (mainly in para position) with C12-rich branched alkyl chains from oligomerisation, covering any individual isomers and/ or combinations thereof (PDDP)	–	Toxic for reproduction and endocrine-disrupting properties	Lubricants and fuel system cleaners
1,4-dioxane	123-91-1	Carcinogenic, harmful to human health and the environment	Laboratory chemical, water treatment products, solvent in chemical manufacturing
4,4'-(1-methylpropylidene)bisphenol	77-40-7	Endocrine disrupting properties	Documented uses include in the manufacture of phenolic and polycarbonate resins

If a product contains a substance listed on the Candidate List above 0.1 per cent, there is a requirement to share information with downstream users in the supply chain. 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.

SCIP database obligations

An important legal obligation is in force in the European Union (EU) regarding substances of very high concern (SVHCs). For any product placed on the EU market since 5th January 2021 that contains an SVHC above 0.1 per cent, there must be information about both the product and the SVHC entered onto the SCIP database, which was created by the European Chemicals Agency (ECHA). It was first introduced under the Waste Framework Directive and is intended to be a central hub for information about SVHCs in articles and products. Before the SCIP database was introduced, there was a concern that this information was not readily available at the waste stage, and that waste operatives may therefore have not known the most efficient way to dispose of these products – or if they were able to be re-used.

What are the new obligations?

This new obligation is not dissimilar to the requirement already in place under REACH for information sharing down the supply chain if an SVHC is present above 0.1 per cent in articles. However, this information will soon be more readily available for a wider audience via the SCIP database than it previously was. Not only will waste operatives be able to access this information, but also different authorities will have the opportunity to monitor the use of these substances and hopefully use this information to focus on the need for less harmful substitutions.

Consumers will also be able to access this information, which will help to foster a growing awareness in the general public about hazardous substances in products. Consumers should then be able to make informed decisions on whether they would want to purchase an article or product containing a potentially hazardous substance. As a result of the SCIP database, ECHA hopes that alternatives to SVHCs will be used by manufacturers in articles and products, and so information about those substitutes will not need to be provided.

Who is affected by this obligation?

A supplier of an article, defined as ‘any producer or importer of an article, any distributor or other actor in the supply chain who places an article on the market’ – and any company that supplies a product that contains a SVHC – is required to make a notification to the SCIP database. This obligation starts with the first supplier in the supply chain based in the EU. Other downstream users (such as distributors or retailers) would be able to refer to the information already submitted. If a company is not based within the EU – for example, it is in the UK – it does not have a legal requirement to notify the SCIP database. However, if its customers are importing the product into the EU, the company is likely to be asked to supply information to fulfil this requirement, to enable the importer to make the notification.

Placing and making available on the EU market

In very simplistic terms, ‘placing on the market’ is defined as when an individual product is made available on the EU market for the first time. Hence, it is transferred, with the intention of distribution, from the stage of manufacture (if production is within the EU) or transferred from the importer (if production is outside the EU). The only economic operators that can ‘place product on the market’ are therefore manufacturers or importers.

‘Making available on the market’ is when an individual product, already ‘placed on the market’ is supplied on the EU market for distribution, consumption or use, so would be typically further down the supply chain. When ‘made available on the market’, products must have been in compliance with the relevant EU legislation applicable at the time of ‘placing on the market’. Please note the published official definitions of these two terms include much greater detail so these descriptions should not be taken as authoritative text.

Testing at SATRA

SATRA can help to ensure that you uphold this duty by being able to provide targeted testing for these SVHCs on products. As previously mentioned, there are 219 chemicals currently listed in the Candidate List (as of July 2021), so it would be very difficult and expensive to test for each substance individually on every article – and even more so if it contains multiple materials. To reduce this strain on testing budgets, SATRA undertakes a targeted approach to assessing articles. Where possible, screening tests are conducted, such as for the metal-containing SVHCs which can all be evaluated simultaneously.

When we assess the substances and therefore identify the tests that are relevant to an individual article, we consider the materials present as some substances are more relevant to specific materials. For example, phthalate plasticisers are likely to be present in flexible polyvinyl chloride (PVC). We also enquire whether a treatment has been added to the material, such as a flame retardant or a water-resistant coating, as some of the SVHCs in question are used for this purpose.

An accurate assessment requires understanding if a treatment – such as a water-resistant or flame retardant coating – has been added, as some SVHCs are used for these purposes

In summary

Once a product has been found to contain a substance listed as a substance of very high concern greater than 0.1 per cent, there is now an obligation to create a notification on the SCIP database if this product is being sold within the EU. This notification must be submitted within six months of the SVHC being added to the Candidate List. If you require testing to determine whether the notification may be applicable, SATRA is able to assess the materials in articles and provide a testing matrix based on the relevant substances that could be present in your products.

How can we help?

Please contact SATRA's chemistry team (chemistry@satra.com) for assistance with testing in line with REACH legislation.

Publishing Data

This article was originally published on page 30 of the September 2021 issue of SATRA Bulletin.