Understanding REACH legislation and California Proposition 65

Considering legal requirements in Europe and the USA.

Millions of people around the world rely on gloves to provide protection against hazards to which they are exposed in their places of work or during their day-to-day lives. It is therefore vital that such products are fit for purpose and do not pose any harm to the wearer.

In the majority of cases, gloves which are marketed as personal protective equipment (PPE) within the EU or UK will be certified in accordance with the PPE Regulation ((EU) 2016/425), and will undergo assessment by a Notified Body or an Approved Body to ensure that all legal requirements have been met. This enables them to bear the CE and/or UKCA mark. However, this assessment does not always include additional legal obligations that a manufacturer or importer must meet in order to place a product onto the market.

Such additional requirements – for example, regarding restricted substances that impact the environment – apply to all products, not just PPE. Although these legal obligations are not subject to assessment by a Notified Body or an Approved Body, it is essential that manufacturers and importers are aware of them and take steps to ensure compliance, as failure to do so can have significant legal repercussions. Many producers of gloves operate on a global scale, so they will need to consider the legal requirements of all countries into which they supply. This article will examine key pieces of legislation relevant to the European and US markets, and discuss the obligations that companies supplying into these areas must meet.

Requirements in Europe

Within Europe, all companies which produce or use chemicals – or which place articles on the market – must meet the requirements of REACH Regulation (EC) 1907/2006. This legislation came into force on 1st June 2007, and aims to improve the protection of human health and the environment from the risks posed by chemicals. It is implemented and overseen by the European Chemicals Agency (ECHA), based in Helsinki, Finland.

Following the United Kingdom’s exit from the EU at the start of 2021, the UK enacted its own version of the REACH regulations – ‘UK REACH’ – which currently mirrors the EU regulations and is overseen by the UK Health and Safety Executive (HSE).

REACH applies to all chemical substances – not only those utilised in industrial processes, but also in those used in everyday life and those present 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, gloves are classified as articles and need to comply with the relevant parts of REACH.

Annex XVII

There are two main parts of REACH of which suppliers of gloves to the EU and UK markets will need to be aware. The first is ‘Annex XVII – Restrictions on the Manufacture, Placing on the Market and use of Certain Dangerous Substances, Preparations and Articles’, which places absolute limits on the levels of harmful substances that are permitted to be present in articles. Compliance is mandatory, and products which do not meet the requirements cannot be legally placed onto the market.

Many of the substances restricted within Annex XVII of REACH are also included in innocuousness requirements of product-specific standards, such as the general requirements for protective gloves, EN ISO 21420:2020. It could therefore be assumed that gloves will not require a separate assessment to show compliance with REACH Annex XVII. However, as REACH is an evolving legislation which is being continually updated, there may be instances where substances restricted under REACH are not included in innocuousness requirements, if the specific standard has not yet been updated to reflect current requirements. In such cases, Notified Bodies may require additional testing to be carried out to show compliance with REACH Annex XVII before they are able to certify the product.

SVHCs

The second part of REACH that is relevant to glove manufacturers and suppliers is the ‘Candidate List of Substances of Very High Concern’ (SVHCs). These are chemicals that have been proposed as potentially hazardous by EU member states, and are awaiting evaluation before further restrictions are imposed.

In order to be considered as SVHCs, chemicals must meet certain criteria. They must either be classified as Category 1A or 1B CMRs (carcinogenic, mutagenic or toxic to reproduction), be either ‘persistent, bio-accumulative and toxic’ (PBT) or ‘very persistent and very bio-accumulative’ (vPvB), or cause an equivalent level of concern as CMR or PBT/vPvB substances. There are currently 241 substances included on the Candidate List as of June 2024, and this is updated twice annually, usually in January and July.

Unlike the substances listed within Annex XVII of REACH, SVHCs are not banned outright. However, certain obligations apply if they are present in a product at 0.1 per cent or above, based upon the total weight of the article. Primary responsibility for compliance lies with the manufacturer or first importer into the EU (or the UK, in the case of UK REACH). Of course, retailers and distributors who are buying in the EU should check that their suppliers understand and have implemented their obligations with respect to SVHCs.

The aim of these obligations is to promote information sharing on the use of potentially hazardous substances through the supply chain, and to encourage the replacement of such substances with less harmful alternatives. To this end, suppliers of articles containing an SVHC in excess of the 0.1 per cent threshold must provide information of this to downstream users, including any applicable information about safe use of the product.

Consumers can request information on SVHC chemicals from the supplier or retailer, and these companies are obliged to provide a response within 45 days. If an individual organisation imports more than 1 tonne of the SVHC into the EU each year, it has a responsibility to notify ECHA of this fact. Such a notification must be made within six months of a substance being added to the Candidate List, so it is essential that companies stay up-to-date with changes to the legislation.

The same obligations apply for substances being brought into the UK. In this case, however, the notification would be made to the HSE, which oversees UK REACH. Where the level of an SVHC in a product exceeds the 0.1 per cent threshold, companies have since January 2021 also needed to submit a notification to the ‘Substances of Concern in articles and Products’ (SCIP) database, providing details of the product and the SVHC present. This requirement applies regardless of the total amount of the SVHC imported into the EU each year. Currently, there is no equivalent database in operation within the UK.

Chemical compliance in the USA

Chemical compliance within the United States of America is a complicated subject, as there is currently no Federal legislation relating to the use of harmful substances in consumer goods. Instead, individual states impose their own regulations. One of the most well-known is ‘California Proposition 65’, and companies placing products onto the market in California will need to ensure that they are aware of and comply with this legislation.

Originally introduced in 1986 as the ‘Safe Drinking Water and Toxic Enforcement Act’, which placed limitations on the levels of harmful chemicals discharged into sources of drinking water, the legislation has since evolved to include obligations for suppliers of consumer goods. California Proposition 65 currently lists over 900 chemicals which are known to be carcinogenic, toxic to reproduction or to cause birth defects.

Importantly, the presence of these substances in consumer goods is not restricted, meaning that products containing the chemicals can still be placed on the market. However, it does require that any business which exposes the public to a listed chemical provides adequate warnings, in the form of a label visible to the consumer at the point of sale. Companies can face significant legal penalties if they fail to provide such a warning where required – up to USD 2,500 per violation per day.

California Proposition 65 is overseen by the state’s Office of Environmental Health Hazard Assessment (OEHHA) and is officially enforced by the California Attorney General’s office. However, as well as these official entities, any group or individual acting in the public interest may file a lawsuit against a company that is alleged to be in violation of California Proposition 65 and will receive a portion of the fines should the lawsuit be successful. This means that any business which does not include an adequate warning label on its product is at risk of being targeted by consumer advocacy groups, law firms or private citizens who are seeking to financially benefit from reporting what they suspect to be a violation.

Safe harbour levels

In order to comply with California Proposition 65, a business must either be able to prove that its product does not contain any of the listed chemicals at levels which pose a significant risk to the consumer or provide a warning label for the product if this cannot be demonstrated. Several of the chemicals included on the list have been assigned ‘safe harbour levels’, which are levels of exposure below which the chemical is considered to not pose a risk.

Crucially, the safe harbour levels are not based upon the total concentration of the chemical present in the product, but rather upon the amount that the user would be exposed to, expressed in micrograms per day (μg/day). This can present challenges for companies to demonstrate that the exposure would fall below this level. If no listed chemicals are present in the product, or if the total amount present is below the safe harbour level, it can be inferred that exposure will not occur, and a warning label is not required.

However, if the amounts of any listed chemicals present in the product exceed the safe harbour level, further calculations will be needed to ascertain the exposure of the consumer in order to demonstrate that a warning label would not be required. Currently, only approximately one-third of chemicals listed have a safe harbour level, meaning that a warning label will be required for the majority of substances if they are present at a detectable level.

California Proposition 65 requires that warnings be clearly visible to the consumer at the point of sale – usually taking the form of an affixed label. Consideration must also be given to online purchases, where the warning must either be present on the product page or accessible through a hyperlink. Although there is no penalty for including an unnecessary warning label, this is strongly discouraged by OEHHA, as it undermines the purpose of the legislation and will ultimately be harmful to both consumers and the businesses involved.

Testing strategies

Working in line with REACH Annex XVII, California Proposition 65 restrictions and the legal obligations concerned with SVHCs, testing a product against the full list of substances would place a significant financial burden on the supply chain. Declarations by manufacturers that the listed substances are absent are seen as industry good practice in conjunction with some laboratory testing regime.

Fortunately, performing full testing is rarely necessary, as some of the chemicals listed have very specific uses and would not be applicable to supported or unsupported gloves. Furthermore, because products can still be placed on the market if they contain substances listed in California Proposition 65 or the Candidate List, the focus of a testing strategy is to provide insight into which legal obligations apply and to protect the company in the event of an allegation being made.

Therefore, a risk assessment approach is recommended. This relies upon knowledge of the materials used in a product, and an understanding of which substances these may contain. As well as considering substances which are deliberately used in the formulation, consideration must be given to by-products, derivatives or contaminants that could be introduced during the production process. For example, polycyclic aromatic hydrocarbons (PAHs), which are included within REACH Annex XVII, California Proposition 65 and the Candidate List of SVHCs, can arise from contamination within extender oils used in the rubber manufacturing process.

In some cases, screening testing can be used to assess a material for multiple substances using a single determination. This is particularly effective for testing 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 many metallic elements. Results from these tests can give confidence that specific SVHCs are absent, and they can also be used to test for heavy metals included within California Proposition 65. Alternatively, such tests could prompt further investigation if concerns are indicated.

In conclusion

To summarise, in addition to the product-specific requirements that must be met in order for gloves to bear the CE and/or UKCA marks, there are additional obligations of which companies should be aware when selling into the European and US markets. Such obligations will not usually be assessed by Notified Bodies or Approved Bodies as part of the certification process, as they relate to the sharing of information rather than prohibitions on placing the product onto the market.

Nonetheless, failure to meet these obligations can have severe legal consequences, and so it is essential that companies are aware of their responsibilities and take steps to ensure compliance. The key pieces of legislation to be aware of are REACH within the EU and UK, and California Proposition 65 in the USA. These are quite complex pieces of legislation, imposing restrictions upon hundreds of different chemical substances, not all of which are applicable to the glove industry.

Understanding the requirements and how they relate to specific products can be a daunting prospect. SATRA can carry out targeted testing for substances included within REACH and California Proposition 65, and can assist companies by assessing products to identify high risk substances and advise upon a comprehensive and efficient testing strategy.

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