REACH

New REACH substance declaration requirements every 6 months

Starting from August 2009 the REACH Candidate List of Substances of Very High Concern (SVHC) will be updated every six months. A draft list will be published in February and August each year and the European Chemicals Agency intends to add about 25 substances per year to the list. The declaration requirements start immediately that the new list is published. The European Chemicals Agency (ECHA) Guidance on Requirements for Substances in Articles notes that component suppliers and equipment manufacturers who supply to businesses are required to inform their customers “automatically i.e. directly after the substance is included in the Candidate List”. For products supplied to households, the manufacturer must provide substance declarations within 45 days of request.

The ECHA Guidance also notes that

"Supply chain communication is the most important and effective way of gathering the information needed to identify compliance obligations under REACH. In this regard, establishing communication standards for the supply chain is an important task for the private sector in order to facilitate the implementation of REACH."

BOMcheck provides this communication standard.

"Philips has decided not to receive REACH compliance information individually from each of our suppliers each time a new list is published” said Jan-Willem Scheijgrond, Senior Director Environment, Health & Safety at Philips Corporate. “Instead, we require all of our suppliers to comply with these REACH obligations by joining BOMcheck - the centralised, open-access substances declarations web database."

Need for expert guidance on SVHC substances in the supply chain

One of the biggest issues that component suppliers face is accessing expert knowledge on where these substances of very high concern are found in the supply chain. For example, many suppliers have focussed their attention on flexible PVC as the most likely source of the DEHP and DBP reprotoxic substances in their products. However, DEHP and DBP are also found in nitrile butadiene rubber (NBR) which is commonly used in many household and industrial products. Recent samples of NBR components manufactured in China and Taiwan have found concentrations of DEHP and DBP of up to 20% w/w.

REACH Article 33 substance declarations

In January 2022 the number of substances of very high concern (SVHC) on the REACH Candidate List Substances increased to 223. Article 33 of the REACH Regulation requires companies who supply products which include any article which contains more than 0.1% by weight of any REACH Candidate List Substance to provide their customers with “sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.” To assist companies to manage their regulatory burden, BOMcheck has published a screening for Supplied Articles which reduces the time and cost for REACH compliance by 60%.

The European Chemicals Agency (ECHA) “Guidance on Requirements for Substances in Articles” contains several recommendations for companies to use industry sector knowledge to assess which REACH Candidate List substances to expect in certain types of parts and materials and which substances can be ruled out of being present. The ECHA guidance states that supply chain communication is the most important way of gathering information about REACH Candidate List substances and recommends that industry should establish communication standards and systems.

The BOMcheck standardized materials declaration system works with the IEC 62476 materials declaration standard to implement these ECHA recommendations for Supplied Articles. BOMcheck has published a REACH Candidate List screening to help companies to save time and reduce costs for REACH compliance by screening out 116 substances which are not normally found in parts and materials in Supplied Articles. Companies can use this screening to reduce the number of REACH Candidate List substances that they need to investigate from 223 down to 104.

The BOMcheck regulatory compliance declaration tool builds on this screening and provides detailed chemicals guidance for each REACH Candidate List substance. The guidance shows that 14 of the remaining 104 substances are only found in exotic materials and components, which means that the regulatory compliance burden at most suppliers is reduced by 60%.

Suppliers can rely on the chemicals guidance to identify materials and parts which are at risk of containing some of the 104 substances used in Supplied Articles. If the guidance indicates that the supplier’s materials and parts are not at risk of containing a particular REACH Candidate List substance (for example, because the substance is used in PVDF plastic and the parts do not contain this type of plastic) then the supplier can claim compliance without additional efforts. The guidance helps the supplier to investigate substances which may be present in their parts and materials by providing information on known uses, typical addition rates and common trade names.

Saving time and reducing costs for REACH compliance has become even more important since the European Court of Justice ruling published 10 September 2015. The ruling imposes new duties on successive companies all along the supply chain to provide information on REACH Candidate List substances in individual component articles. In particular, the producer of the finished product is required to inform their customer if any component article in the product contains a REACH Candidate List substance in a concentration > 0.1% w/w of the component article.

REACH Article 67 substance restrictions

From 1 June 2009 all EU suppliers are now required to comply with a raft of substance restrictions under the REACH Regulation. The substance restrictions apply every time an article is supplied (including components, sub-assemblies and finished equipment) and enforcement action can be taken at any point in the supply chain. The substance restrictions also apply to distributors who resell components and sub-assemblies, and retailers who resell finished equipment.

The 53 substance restrictions are detailed in Annex XVII of the REACH Regulation (as amended) and cover a very wide range of applications. In addition to substances which are already restricted under the Restriction of Hazardous Substances (RoHS) Directive, there are a further 19 REACH substance restrictions which can be relevant to electrical and electronic equipment and hardware products.

More substances will be added to the list by the European Chemicals Agency and EU Member States. However, the list of REACH restricted substances will develop more slowly than the REACH Candidate List of Substances of Very High Concern, which may grow by up to 25 substances per year according to the European Chemicals Agency. Substances on the Candidate List require declaration if the component, sub-assembly or finished equipment contains more than 0.1% w/w of that substance.

REACH enforcement is carried out through Member State regulations and is coordinated across Europe by the ECHA Forum for Exchange for Information on Enforcement. In France companies that do not comply with the REACH substance restrictions face a maximum prison sentence of two years or a maximum fine of €75,000. In the UK non-compliant companies face a maximum penalty on conviction on indictment of a fine (unlimited) or imprisonment not exceeding two years, or both.

The enforcement action taken by the Netherlands against Sony in 2001 under the old Marketing and Use Directive illustrates the level of enforcement that may be applied for non-compliance with the REACH substance restrictions. In May 2001 a competitor informed the Dutch customs that cables in Sony PlayStation1 contained 20 times the levels of cadmium permitted in Dutch regulations implementing the Marketing and Use Directive. Annex XVII of REACH replaces the Marketing and Use Directive and specifically prohibits the use of cadmium in concentrations > 0.01% in PVC used for insulation for electrical wiring. Dutch customs seized 1.3 million PlayStation1 units and 800,000 accessories with a market value of $162 million. Replacing the cables and safety validation to enable these units to be sold in the Netherlands cost Sony $110 million. The business impact of lost sales of PlayStations in the Netherlands during this period has not been quantified. It is interesting to note that the Netherlands leads the ECHA Enforcement Forum working group on the enforcement of the REACH substance restrictions.