Regulatory compliance for chemical, cosmetic and biocidal products.
REACH
REACH and Extended Safety Data Sheets
Safety data sheets: the story so far
The safety data sheet (SDS) is the main tool for hazard communication in the supply of chemical products. However, much criticism has been aimed at the SDS. The 2004 ECLIPS report [ref 1] catalogued many serious errors in SDSs, and concluded that the compliance of SDSs with the legislation must be improved. This lack of compliance on the part of industry is compounded by a dearth of hazard information, particularly on existing substances (those on the market before September 1981). The EU Commission have stated, ‘as little is known about the intrinsic properties of existing substances, it can be assumed that the majority of these chemicals cannot be properly classified today and adequate risk management measures cannot be taken.’
In addition to the lack of information on the intrinsic hazard, is the lack of information concerning the way chemicals are used in the workplace. Therefore, it has been very difficult for risk assessors to find useful information on exposures.
As a consequence, workers may find themselves at risk of occupational disease. In its ‘REACH in Brief’ document [ref 2], the EU Commission states that ‘diseases caused by chemicals were assumed to account for some 1% of the overall burden of all types of disease in the EU.’
REACH (EU Regulation 1907/2006) will replace the current SDS Directive (91/155/EEC), and therefore gave the European Commission a clean sheet to improve SDSs and provide a safer working environment. This paper outlines the changes to the SDS that REACH requires, and assesses the impact on occupational safety.
REACH and protection of human health and the environment
REACH has the typical structure of EU legislation: it comprises:
a) 131 recitals, giving the aims and context of the legislation
b) 141 articles, collected into 15 Titles, giving the main provisions and procedures. Title IV, Article 31, gives the ‘Requirements for Safety Data Sheets’
17 annexes, giving detail to some of the articles, including as Annex II the ‘Guide to the Compilation of Safety Data Sheets’
The protection of human health and the environment is one of the main objectives of REACH. Other stated goals are the enhancement of competitiveness in the EU chemicals industry, integration with international efforts, and promotion of non-animal testing. The aims pull in different directions, and compromise is required to find a suitable balance. The protection aim, relevant for the discussion on SDSs, is evident from the recitals, eg:
‘This Regulation should ensure a high level of protection of human health and the environment…(1)’
How is the protection goal administered
The main tool for protection of human health is risk assessment.
To assess such a risk, the assessor firstly requires information on various hazardous endpoints (hazard identification; eg sensitisation, reproductive toxicity). In REACH, this is achieved through mandatory testing requirements for registration.
The hazards are compared to the estimated exposure under reasonably foreseeable circumstances, and the ratio of the two figures gives a margin of safety (sometimes called margin of exposure). Where the margin of safety does not give re-assurance of adequate protection, then further risk measurement measures (RMMs) should be introduced to decrease the expected exposure, and thereby increase the margin of safety.
Hazard identification, risk assessment and RMMs are also a prominent feature of the REACH recitals, eg:
‘All available and relevant information on substances on their own, in preparations and in articles should be collected to assist in identifying hazardous properties, and recommendations about RMMs should systematically be conveyed through supply chains, as reasonably necessary, to prevent adverse effects on human health and the environment... (17).’
The risk assessment in REACH is formalised for substances supplied at >10 t, and called a chemical safety assessment (CSA), which is documented in a chemical safety report (CSR) (see REACH Articles 14 and 37, and Annex I).
The role of the SDS in hazard communication
The main tool for communication of the hazards and RMMs is the SDS. Hazards are identified in Sections 2, 3, 9, 11, and 12 of the SDS; RMMs are mainly given in Section 8. The REACH recitals confirm the continuing role of SDSs as the primary hazard communication tool, eg:
‘As the existing safety data sheet is already being used as a communication tool within the supply chain of substances and preparations, it is appropriate to develop it further and make it an integral part of the system established by this Regulation (57).’
The Articles, particularly Article 31 ‘Requirements for Safety Data Sheets’, give information on when and how SDSs should be provided. These are generally in line with current practices, except that an SDS should also be provided for substances, or preparations that contain a substance above a threshold value, that are:
a) Classified as persistent, bioaccumulative and toxic (PBT) or very persistent, very bioaccumulative (vPvB) in accordance with criteria given Annex XIII
b) On the candidate list for inclusion in Annex XIV (substances subject to authorisation, eg endocrine disruptors).
Main changes in SDSs under REACH
There are many changes to the SDS given in the REACH regulation, and more are recommended in the REACH Implementation Project (RIP) on SDSs [ref 3]. A list of changes is available in the Annex (below). The main changes under REACH which affect the SDS are as follows:
Section 2 will be the ‘hazards identification’ and Section 3 ‘composition/information on ingredients’. This constitutes a reversal of these Sections compared to current practice. This re-formatting is to bring the EU SDS in line with international SDS requirements under the United Nations Globally Harmonised System (GHS) [ref 4]. Classification and labelling parts of the GHS currently being introduced into the EU, and draft legislation is available [ref 5]. The GHS will replace the current system of classification and labelling (under the UK CHIP regulations), and will introduce new hazard symbols.
Section 12 should include the results of the PBT and vPvB assessment. The assessment should be performed on ingredients to determine if any are persistent (P), very persistent (vP), bioaccumulative (B), very bioaccumulative (vB), or toxic (T) according to criteria in Annex XIII of REACH. Such substances pose a threat to human health through their potential to remain for long periods in the environment, and accumulate in fatty tissues of organisms. So far, such substances have been poorly regulated and controlled.
A further important initiative within REACH is the classification and labelling inventory. Mandatory classifications of substances, currently given in Annex 1 of 67/548/EEC (the UK Approved Supply List), will be taken into REACH. The new European Chemicals Agency (ECHA), to be based in Helsinki, will classify substances that are carcinogens, mutagens, or reproductive toxicants (CMRs), or respiratory substances, and add these to the inventory. Industry will be largely responsible for classification of substances with other hazardous properties. The intention is that the inventory will establish industry-wide consensus and harmonisation, compared to the often disparate self-classifications of the same substance under the current scheme. The inventory will begin 1 December 2010. The classification database is mentioned in recitals 112 and 113, with detail in Title XI.
Exposure scenarios and the extended SDS
The biggest change to the SDS under REACH is the addition of an Annex containing the exposure scenario(s) (ES) derived from the CSR, to give the so-called extended SDS (extSDS). An extSDS is therefore required only for >10 t and PBT/vPvB substances. Thus, Article 31.7 states:
‘any actor in the supply chain who is required to prepare a CSR (Articles 14 for M/Is or 37 for DUs) shall place the relevant exposure scenarios (including the use and exposure categories where appropriate) in an annex to the SDS covering identified uses…’
Development of exposure scenarios
So what is an ES? Annex 1 of REACH states:
‘An ES is the set of conditions that describe how the substance is manufactured or used during its life-cycle and how the M/I controls, or recommends DUs to control, exposures of humans and the environment. These sets of conditions contain a description of both the RMMs and operational conditions which the manufacturer or importer has implemented or recommends to be implemented by downstream users.’
ESs cover any manufacture in the Community and all identified uses. The assessor develops an initial ES, which is tested through risk assessment in an iterative process, which leads to a final ES that is attached as an Annex to the SDS.
The ES includes a description of:
- Use
- Operational conditions
- Processes, including the physical form of substance
- Activities of workers and consumers, and their duration and frequency of exposure
- Duration and frequency of emissions to the environment, and the dilution in receiving compartment
- Risk management measures
- RMMs to reduce exposure to the substance of humans, and the environmental compartments (including waste management).
The large number of tasks to be described in the ES presents a problem, in terms of both definition of terminology, and the DUs ability to identify if their control measures are sufficient. For purposes of clarity, a simple task descriptor needs to be generated for each operational condition and RMM. An inventory of such descriptors is under construction. Such descriptors would also allow automatic production of the ES through SDS authoring software. Also, instead of specific ESs, assessors may develop use and exposure categories. These are generic descriptions of operational conditions and RMMs which cover multiple uses, and may also help in protecting proprietary information.
Despite these provisions, the ES Annex to the SDS could prove enormously bureaucratic. A DU may be faced with multiple ESs attached to a single SDS, and have to decide their relevance to using a particular substance or preparation in a particular way in the workplace. It is likely that many DUs, particularly small and medium enterprises, will lack the expertise to make such judgements. The Commission have commented in the SDS RIP: ‘The ES probably represents the greatest challenge for the extSDS in terms of presenting the essential information in a comprehensible format.’
Timings and action points
There is some argument over whether the ‘old’ UK regulations are repealed on entry into force of REACH on 1 June 2007. Consensus is that they are not until positively repealed, but this leads to a conflict between UK and EU laws. At least one commentator believes SDS changes are required on 1 June 2007. Some regard the REACH Annex II as guidance, and that the switch in Sections 2 and 3 of the SDS do not constitute a significant change, so old style SDS will be OK after the 1st June. vPvBs and PBT may require an SDS after 1 June, but CEFIC suggest they are not required until the assessment against the criteria is done, dependent on the deadline for registration. A meeting of the Commission Working Group should help clarify these issues.
What to do now?
In order to determine the impact of REACH for your company, it is necessary to make an inventory of chemicals that are handled (which in turn requires the composition of preparations), along with identifiers (CAS and EC numbers), and the tonnages which are handled by your company. For each chemical, decide whether you are the M/I with responsibilities for registration and the development of ESs, or whether you are a DU.
With regard to ESs, M/Is should collate the parameters needed to describe ESs for manufacture and known uses above 10 t. The parameters include those for the process description, operating conditions, and RMMs outlined above. The descriptors used in the current Technical Guidance Document for Risk Assessment, namely Industry Category, Main Category, and Use Category, may be helpful, although better guidance on standard descriptions should be available soon. M/Is should be asking their customers for details of processes, so that these can be covered in the CSR and extSDS.
DUs should confirm with their supplier that chemicals they use above 10 t are covered by the supplier’s CSR and extSDS. Such a supplier has the option of completing the CSR and extSDS themselves, or passing details of the use further up the supply chain, if necessary as far as the M/I. If the DU does not wish to divulge details of his use, then he is obligated to compile the CSR and extSDS for his customers.
Conclusions
REACH is good news for occupational health and safety. There will be more information on both hazard and exposure, so that uncertainty in workplace and environmental risk assessment will be substantially reduced. In particular, the ca. 30 000 ‘existing’ substances will require testing to a minimum level, based on supply tonnage and hazard.
Uncertainty regarding classifications will eventually be reduced through the classification and labelling inventory. The inventory is mostly self regulating, with harmonised classifications for CMRs (cat. 1, 2, and 3), respiratory sensitisers, and other special hazards.
The SDS will remain largely the same for substances supplied at <10 t. For substances supplied at >10 t, an extSDS is required. This extSDS has an Annex which describes the ES, derived from the CSR. DUs will have to work within the ES, or develop their own. The ES will prescribe the operational conditions and RMMs necessary for safe use.
Work is required now to inventorise chemicals and their uses. The challenge remains as to how to use simple, universally understood descriptors for chemical processes, and how to incorporate these in the extSDS in a concise and comprehensible manner.
Annex: List of changes to the SDS under REACH, compared to current requirements
The main changes for the new SDS under REACH are given below, based on current recommendations.
Section 1. E-mail of competent person responsible for the SDS should be added. Registration number added. It is recommended (see SDS REACH Implementation Project; SDS RIP) that the use heading in Section 1 should be generic use conditions (closed systems, open systems operated by trained staff, etc) and application conditions (use in textiles, printing inks, etc.)
Sections 2 and 3 are reversed, compared to current practice.
Section 3 (information on ingredients). PBTs and vPvBs should be mentioned if present at > 0.1%. Registration numbers should also be given, when available.
Section 8. Where a chemical safety report is required, the relevant DNELs (health) and PNECs (environment) for the substance shall be given for the exposure scenarios set out in the annex to the SDS. Summary of the RMMs for both health and the environment are required here too, for the ESs given in the annex to the SDS. For preparations, it is useful to provide values for those constituents which are required to be listed in the SDS in Section 3. The SDS RIP notes that the RMMs may more logically be put in Section 7.
Section 11. Information on toxicokinetics, metabolism and distribution. Statement on the CMR category 1 or 2 status of the substance or preparation.
Section 12. Results of the PBT/vPvB assessment, and the emission characterisation (only required if the PBT and vPvB conditions are met) shall be summarised in Section 12 of the SDS. Effects such as ozone depletion, photochemical ozone creation potential, and strong odour and tainting should be summarised in the SDS for substances with chemicals with a CSR. Information, if available, on endocrine disrupting potential should be included.
Section 15. Indicate if a Chemical Safety Assessment (CSA) has been carried out for the substance, or a substance in the preparation. Authorisation under Title VII and restriction under Title VIII and relevant national measures applied to the substance should be mentioned here.
Section 16. Full R and S phrases as usual, but also reasons for inclusion in Section 3 if appropriate (ie PBT or Community workplace exposure limit). Uses advised against (recommended restrictions on use; non-statutory recommendations by the supplier).
References
1. European Classification and Labelling Inspections of Preparations, Including Safety Data Sheets (ECLIPS); European Enforcement Network; June 2004. Web copy available at: http://www.umweltbundesamt.at/en/ [ back to article ]
2. REACH in Brief; European Commission; December 2006. web copy available at: http://ec.europa.eu/enterprise/reach/index_en.htm [ back to article ]
3. Safety Data Sheets Requirements Under REACH; RIP 3.2-1A; web copy available at: http://ecb.jrc.it/reach/rip/ [ back to article ]
4. Globally Harmonized System of Classification and Labelling of Chemicals (GHS); United Nations; 2005; web copy available at: http://www.unece.org/trans/danger/publi/ghs/ghs_rev01/01files_e.html [ back to article ]
5. The draft EU legislation for the implementation of the GHS is available at: http://ec.europa.eu/enterprise/reach/ghs_consultation_en.htm [ back to article ]
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