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Päivi Jokiniemi and Paul Trouth
Article related to: REACH
Improving compliance with restrictions
ECHA’s Enforcement Forum’s latest project (REF-4) has shown serious breaches in compliance with restrictions, for example, for asbestos, plasticisers and mercury in consumer products. We look at the results of the project and what lessons can be learnt by enforcement authorities and companies.
The aim of the project was to understand the degree to which restrictions are being complied with and, where necessary, to follow up with enforcement actions. It covered 14 entries from the list of substances restricted under REACH (Annex XVII). The overall goal is to improve the level of compliance with restrictions and, in doing so, protect our health and the environment.
What was found?
5 625 inspections were carried out in total for more than 1 000 mixtures, nearly 4 600 articles and 17 substances. The average non-compliance rate was 18 %.
Given that restrictions are put in place for uses of chemicals that pose the highest risk to health or the environment, this number is too high. Enforcement authorities tend to work on cases where they are likely to see the most non-compliance and, for this reason, the results are not deemed to cover all related products on the European market.
The highest non-compliance rates were for phthalates in toys, asbestos fibres in products, as well as mercury in measuring devices – an entry inspected outside the scope of the main project.
There were also high levels of non-compliance for cadmium in brazing fillers and jewellery, chromium (VI) in leather articles, nickel in metal parts of clothing, and polycyclic aromatic hydrocarbons (PAHs).
Plasticisers in toys and chromium in leather
The restriction of phthalates was done to protect children from the harmful effects of chemicals. Some phthalates are suspected of being toxic for reproduction and endocrine-disrupting. Under REACH, restrictions apply to toys and childcare products containing phthalates in concentrations above 0.1 % by weight of the plasticised material that can be placed in the mouth by children.
As such, it is alarming that the presence of phthalates in toys is so high – almost 20 % of more than 460 inspected products contained higher levels of the phthalates DEHP, DBP and BBP than they should, and 10 % of more than 300 products checked contained too high amounts of the phthalates DINP, DIDP and DNOP.
Inspectors also found overly high levels of chromium VI in leather articles. Chromium VI is restricted in leather articles that touch the skin. The articles cannot be placed on the market if chromium VI is present in concentrations equal or greater to 3 mg/kg. Almost 500 leather articles were tested and more than 13 % breached the restriction.
Asbestos in second-hand products
Asbestos fibres have been restricted in the EU for many years. They can cause cancer of the lungs, larynx and ovaries, and also lung fibrosis. So it is surprising that asbestos was found in nearly 14 % of products checked. The fibres were found in 20 catalytic heaters, three thermos flasks, two brake pads, two cement materials, a sky lantern and a jug flask. In the EU, producing, placing on the market and using these fibres and any articles containing them is banned.
One reason that the fibres may have been found is that many of the articles containing them were second-hand and therefore probably produced before the restriction came into force. However, even if this is the case, selling these products is still illegal if they do not meet the requirements in force today. There are some exemptions to the restriction. If articles containing the fibres were already installed or in service before 1 January 2005, then their use is exempted from the restriction.
Mercury in measuring devices
UK inspectors checked almost 400 measuring devices and nearly 90 % were found to contain mercury above the allowed limit. Mercury is toxic and inhalation of mercury vapours can cause harm to the nervous, digestive and immune systems. The high non-compliance could be because the UK inspectors were using alerts on online auction sites that allowed them to specifically target articles where mercury is indicated as being present and avoid those that are categorised as ‘mercury-free’.
While the devices were only inspected by United Kingdom enforcement authorities, the high proportion of devices that were found to have mercury above the limit suggests that other countries should do similar checks.
Restricted heavy metals in jewellery
Illegal levels of heavy metals are still being found in jewellery used in the EU. Nearly 7 % of inspected items contained lead, 8 % released nickel, and more than 12 % contained cadmium above the respective restriction limits. The risks from heavy metals vary. Nickel can cause skin allergies, cadmium can cause osteoporosis, cancer, and is also toxic to the environment, and lead can cause damage to the nervous system and impair intellectual development.
These rates suggest that the presence of heavy metals in the products is not accidental, but either a result of producers consciously using the raw material during manufacture or lacking sufficient knowledge about what their materials contain.
Lessons to be learnt by enforcement authorities
The key learning that national enforcement authorities can get from the report is that they should target the kinds of products for which regulatory action can bring the most benefit to health and the most protection to the environment. That said, their activities on restrictions should focus on those substances where the highest rates of non-compliance were found: asbestos, cadmium, nickel, phthalates, mercury, chromium (VI), heavy metals in jewellery and PAH compounds.
Enforcers could also target their activities at products that do not contain a marking of origin on their label, or where the origin cannot otherwise be found, as the non-compliance rates were extremely high (39 %).
To prove non-compliance by testing the chemicals onsite, companies and enforcing authorities would need to put systems in place to carry out a chemical analysis. The Forum has prepared a collection of analytical methods to be used as a reference when checking compliance with REACH restrictions.
Developing combined nomenclature (CN) codes – used in export declarations for trade in Europe – for all substances, mixtures or articles restricted under REACH would have a positive effect on the related checks and the involvement of customs, as would streamlined procedures to help enforcement authorities get information from customs. To improve these, more common projects between the enforcement authorities and customs are needed.
What companies can do
All companies placing chemical products or articles on the EU market have to comply with REACH restrictions. This means that the suppliers of products in all steps of the supply chain are responsible. So, if you place products on the market, you should be aware of the chemicals they contain and how they are supplied and by whom.
This may mean proactively testing the products and establishing agreements with suppliers to make sure that the chemical composition of the products in the supply chain is in line with chemicals legislation. Companies should also put systems in place in case a non-compliant substance, mixture or article is found in their portfolio, so they can quickly act to correct the situation.
Companies could also check the RAPEX alert system – an EU portal of products found on the market that pose a serious risk to health or the environment – to get information on non-compliant products found on the market. Restrictions are put in place so that the risks from substances that are harmful for human health and the environment are under control.
Preventing these risks is a legislative and moral responsibility and should be taken seriously at every step of the supply chain. Given the findings of the project report, however, there still seems to be a lot to be done.
|Substances||Products to be tested|
|Benzene||glues for consumers and professionals|
|Cadmium and its compounds||plastic materials/packaging and other articles, brazing fillers and jewellery|
|Nickel and its compounds||jewellery and metal parts such as buttons and zips|
|Chloroform||glues for consumers and professionals|
|Azocolourants and azodyes|| |
textile and leather articles
|Diphenylether, octabromo |
|substances, mixtures and articles|
|Chromium VI compounds|| |
leather articles and cement
|Toluene||adhesives and spray paints for supply to the general public|
substances and mixtures
|Polycyclic aromatic hydrocarbons||articles for supply to the general public|
toys and childcare articles
|Lead and its compounds||jewellery|
|The project covered 14 restriction entries. Mercury was inspected outside the scope of the main project.|
Did you know?
The EU Commission runs an alert system, the Rapid Alert System (RAPEX), which enables quick exchange of information between the Commission and 31 European countries about non-compliant non-food products that pose a risk to the health and safety of consumers.
Text by Jakob Aahauge
Published on: 15 February 2018
Updated on: 23 February 2018 - Nearly 7 % of inspected items contained lead, 8 % released nickel, and more than 12 % contained cadmium above the respective restriction limits.
Top image: © IStock.com/NataliaDeriabina
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