As the first registration deadline under REACH arrives this month, Paul Reeve considers the current implications of the regulation for the downstream users of substances and products.
REACH – the European Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals – is the largest single piece of legislation ever introduced by the European Commission. It aims to: protect people and the environment across the EU from dangerous substances, mixtures and products; make business responsible for assessing the hazards of thousands of substances; improve the exchange of hazard information throughout the supply chain; and ban, or restrict the most dangerous substances from the EU market.
Under REACH, downstream users include:
UK enforcement of REACH is coordinated by the Health and Safety Executive. Although offences under REACH can lead to enforcement notices or prosecution, the HSE’s main role so far has been to advise the various REACH duty-holders on what they need to do. Many agree that it has done a good job of explaining some very complicated legislation.
The HSE’s general advice for downstream users (which includes end users) is: “If you are using (everyday) chemicals or mixtures in the way that is expected, then REACH probably won’t mean significant changes. However, if you rely on using unusual chemicals, ensure that these will still be available. Consider contacting your supplier to find out if the substance (or mixture) will be registered by whoever makes, or imports it.”
The HSE previously advised downstream users to create an inventory of the substances, mixtures, or articles they use. Such an inventory can highlight substances that may be particularly hazardous, or which cannot be readily obtained from another supplier.
“It is possible that some companies may not register (previously supplied) chemicals,” adds the HSE. In this situation, a downstream user may need to find an alternative source, or even look for a new way of carrying out an activity, or making a product. If you are not the end user, your own customers may ask you about the substances, mixtures, or articles in your products or services, and whether they contain anything highly toxic, or harmful to the environment, or are going to be difficult to obtain.
The deadline cometh
With a few key exceptions (e.g. polymers) REACH requires substances available from a manufacturer or importer in the EU at one or more tonnes per annum (tpa) to be registered with the European Chemicals Agency (ECHA). Registration is being phased in across three important dates, the first of which is 1 December 2010. The December date affects substances available from a manufacturer or importer in quantities of 1000 tpa or more, or – significantly – if they are “carcinogenic, mutagenic or toxic to reproduction” (CMRs), category 1 and 2, and available at one tpa or more. Some higher-tonnage substances must also be registered because of environmental hazards.
For registration to be successful the ECHA must accept an extensive hazard data set from registrants for each substance. If a substance categorised above is not registered by December 2010 (or if another does not meet a subsequent deadline) it is illegal to manufacture, import, or supply it within the EU.
Under REACH, anyone who manufactures or imports substances in quantities of 10, or more tpa must also provide the ECHA with a Chemical Safety Assessment (CSA). The CSA covers the hazards and risks, and proposes risk controls for all the “supported” uses of the substance. Registration also requires a chemical safety report (CSR) for substances available at 10, or more tpa, or for a substance that requires authorisation, irrespective of the available tonnage (the content of the CSR is derived from the CSA). To support the 2010 registration process, many suppliers have contacted their main downstream users to find out how they use various substances.
The ECHA recently published a list1 of around 5000 substances set for 2010 registration, together with information on what to do if a substance is not on the list. Under REACH, substances that will continue to be legally available will either be:
The next REACH registration deadline is in 2013 – for substances available from manufacturers and importers at 100-1000, or more tpa – and the full REACH registration process is set for completion in 2018 (covering all remaining substances available at one tpa, or more).
Authorisations and restrictions
“Authorisation” by the ECHA aims to prevent public or environmental exposure to particularly hazardous substances. This includes, but is not restricted to, some substances at work. The bulk of substances in the EU are not sufficiently hazardous to be affected by the authorisation process, but anyone relying on a substance that is a ‘candidate’ for authorisation may find that supply of the substance is at risk.
Authorisation can be applied to substances such as category 1 and 2 carcinogens, mutagens, and those that are harmful to reproduction (CMRs). If these substances are considered (by the ECHA) to present a significant risk because of (for example) the amounts used, and how they are used, they are then referred to as ‘Substances of Very High Concern’ (SVHC). Around 50 substances are already classed as SVHCs, and the number is increasing steadily.
SVHCs will appear in Annex XIV of REACH, along with a ‘sunset date’ by which the use of the substance in the EU must stop, unless any uses are ‘authorised’ by the ECHA. The suppliers of materials or articles that contain >0.1% by weight of SVHC (and which have been placed on the REACH Candidate List)2 should inform customers if SVHCs are present, and provide instructions on the safe use of the product. The need to declare SVHCs may encourage suppliers to “voluntarily” substitute these substances.
In addition to authorisation, REACH includes Annex XVII ‘restriction’ for any substance that poses an “unacceptable risk to health or the environment”. A substance may be subject to restriction – irrespective of the tonnage available – if its risks must be addressed on an EU-wide basis. A REACH restriction may:
Supported uses and exposure scenarios
To register a substance under REACH, an applicant must provide comprehensive health and safety hazard data. This information contributes to the production of Safety Data Sheets (SDSs), plus Chemical Safety Assessments or Reports, if need be.
When a downstream user receives an SDS bearing a REACH registration number, it should:
REACH applies the “supported use” principle, i.e. suppliers decide when and how their products are used, though the decision must be justifiable on health and safety grounds. End users should expect SDSs to contain at least one “exposure scenario” for a supported use if the substance is available from a manufacturer or importer at 10, or more tpa, or classed as dangerous, or with high environmental hazards.
The supplier’s exposure scenario is based on the findings of a CSR. In many cases, the exposure scenario will be simple, but it should also be practically useful. If it is not, users should tell the supplier and ask for clarification.
It may be difficult for a downstream user to get supplier support for an unusual application if there are very few suppliers. Those who have not told their supplier about a “non-supported” use may have to do their own risk assessment and obtain permission for the use from the ECHA. This is not an easy process and it is best to try to get supplier support first.
REACH and COSHH
We should bear in mind that REACH covers not just health and safety but also environmental hazards, and that its main aim is to protect the general public, not just employees. REACH is not designed to replace COSHH, which has the more specific aim of reducing occupational-health risks from substances. In fact, REACH is likely to support COSHH (or DSEAR, its lower-profile relative) by providing extra information that will help duty-holders assess and control occupational health and safety risks.
We have seen that REACH puts responsibility for identifying and assessing chemical hazards on those who place substances on the EU market. If they need to compile a chemical safety assessment (CSA), a REACH registrant must identify Derived No-Effect Levels (DNEL) for human exposure, and set out exposure scenarios that describe the uses that the registrant is ‘supporting’. Increasingly, ‘COSHH data sheets’ will include information on DNELs and supported uses.
However, the comprehensive ‘good practice’ principles already required by COSHH may limit the scope for significant changes to risk assessments, unless a substance is particularly harmful (e.g. a CMR). REACH places duties on users to follow the specific conditions of use if these substances are subject to ‘authorisation’ or ‘restriction’.
Of course, what matters is the protection of workers and others from hazardous substances. Although REACH may ban and restrict some very harmful substances, it is also set to provide much more information on thousands of commonly-used substances, to help end users apply effective workplace control measures.
References
1 http://echa.europa.eu/chem_data/ list_registration_2010_en.asp
2 http://echa.europa.eu/doc/press/ pr_10_12_candidate_list_20100618.pdf
3 http://echa.europa.eu/reach/restriction _en.asp
Further information
The REACH Regulation (1907/2006) was published as in the Official Journal of the European Union (L 396/288) on 30.12.2006
The HSE provides a range of helpful factsheets on REACH (including a downstream user’s guide) at: www.hse.gov.uk/reach/resources.htm
ECHA ‘Guidance for Downstream Users’ is at: http://guidance.echa.europa.eu/docs/guidance_document/du_en.htmt?ime=1254330774
CLP guidance is at: http://echa.europa.eu/doc/clp/clp_leaflet_20091210.pdf
Paul Reeve is head of safety and environment at the Electrical Contractors’ Association.
PANEL 1
For downstream users, reach may mean:
PANEL 2
A long farewell to chip
As if REACH registration were not enough, the EU Classification, Labelling and Packaging Regulation (CLP) is also coming into effect from this month.
The CLP Regulation implements the UN’s Globally Harmonised System (GHS) of packaging and labelling in the EU. CLP applies to the classification of substances from 1 December 2010 and to the classification of mixtures (formerly known as ‘preparations’) from 1 June 2015. A transitional period between the current Chemicals (Hazard Information and Packaging for Supply) Regulations (CHIP), and new CLP regimes ends on 1 June 2015, after which the CLP Regulation takes over entirely.
This means that, over the next few years, users may encounter a dual chemical hazard information system – some packages, labels and safety data sheets will change in line with CLP, while others will trail behind. However, the familiar rectangular orange symbols applied under CHIP will steadily give way to diamond shaped pictograms, with symbols in black on a white background and a red border. Significantly, indications of danger will be replaced with “signal words”, and the long-established “risk and safety” phrases on labels will give way to “hazard statements and precautionary statements”.
However, if a substance or mixture does not need reclassification under CLP, existing SDSs will be valid until 30 November 2012, and substances already “on the shelf” can continue to be supplied as labelled until 1 December 2012. CLP’s Annex VII includes a table for converting classifications under CHIP to the new CLP classifications.
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Simple, well explained article on REACH. Cuts through the complications with ease.