The post ‘Discussions at the Green Ribbon Science Panel – a reality check’ further down describes the rather critical reactions of the Panel members and other participants to the draft Straw Proposal of 1 October at the meeting of the Panel on 14 October.
The draft Regulation was also discussed with a broader range of stakeholders at a public workshop on 21 October 2009 in Sacramento and reactions were equally sceptical. In addition, more than 60 organisations, companies and individuals submitted written comments, which criticised the proposal in similar ways – some also included suggestions for a more appropriate Regulation.
The following recommendations for a more workable approach for the future Regulation in California have been developed against the background of these reactions and with a view of maximising synergies with the work that will be accomplished in the EU in the implementation of the REACH Regulation and the Regulation on Classification, Labelling and Packaging (CLP) that aligns the EU’s rules with the Globally Harmonised System for Classification and Labelling.
1. Identification of substances of concern
The Regulation should limit the hazard criteria to identify chemicals of concern to those hazards that are indeed so severe that they should trigger obligations to substitute the substances by safer alternatives. As a starting point, the Regulation should include the hazard criteria as contained in Article 57 of REACH to identify substances of very high concern (SVHC), which are also recognised in other third countries as of particular concern. These criteria include substances classified as carcinogenic, mutagenic, or toxic to reproduction (CMRs), substances that are persistent, bioaccumulating and toxic (PBTs) or very persistent and very bioaccumulating (vPvBs), or others of equivalent concern, such as endocrine disruptors. If so desired, and even though the criterion of ‘equivalent concern’ as contained in Article 57 of REACH can function as a ‘catch-all’ in case of need, California could add a limited set of further irreversible or chronic effects (e.g. respiratory sensitisation) and possibly also a consolidated ‘list of lists’ with names of substances from other authoritative sources. However, if too many chemicals are identified as ‘of concern’, limited resources are dispersed on too many chemicals rather than focusing on the most serious ones.
2. Scope of Products Covered
Likewise, the scope of products covered by an obligation to conduct alternative analyses should focus on those leading to highest exposures (i.e. substances by themselves, in mixtures, in articles where a release is intended, articles that are used by particularly vulnerable groups etc.). The Regulation should specify ‘de minimis’ concentrations of substances of concern in mixtures and articles so that the presence of trace impurities that are inadvertently present does not trigger the requirement for alternative analysis.
3. Prioritisation of Batches of Chemicals of Concern
As it is not feasible for companies to deal with all substances of concern at the same time, DTSC should periodically select batches of priority substances and trigger the analysis process – where necessary specifying also particular priority products. The specific substances and products for each batch should be identified through a public consultation process involving other government departments and all stakeholders. In selecting priority substances, DTSC should always include substances listed on Annex XIV of REACH, and possibly also those on the candidate list under REACH. In addition to the criteria as set out for ECHA for prioritising substances (substances that are PBTs or vPvBs, are in wide dispersive use or are used in high volume), DTSC could also include biomonitoring data as a reason for prioritising substances of concern, in particular substances found in umbilical cords. Substances included in the various batches of Canada’s Chemicals Management Plan could likewise be included. This would be a very effective way of proceeding – first because the processes under REACH will provide considerable information on the use of the substances and possible alternatives, which will help companies and DTSC to identify products where they do actually occur and to find feasible alternatives, and second because concerted action on these substances both in the EU and in California will have strong impacts on the global supply chains for the manufacturing of products containing the substances concerned, which will create synergies and efficiency gains for both authorities and industry. When deciding on the number of priority substances in the various batches, DTSC should be mindful of its own resources for oversight and control.
4. Realistic Time Periods and Available Data Sources
The time periods both for gathering data on the occurrence of substances in products and for conducting alternative analyses have to be realistic. Experience in both the EU and Canada has shown that replacing problematic substances in products by safer alternatives can take several years. From the date that a batch of priority substances of concern (and possibly also priority products) have been published, companies should have one year to investigate whether they are present in the priority products selected and report this to DTSC. Thereafter, the Regulation should foresee around 3 to 4 years for companies to conduct alternative analyses, where possible replace substances of concern by others, and report the results to DTSC. The first round of alternative analyses should not start before the end of 2011 as by then ECHA will have published on its website a significant amount of information on hazards, exposure and uses of substances from REACH Registration and the classification & labelling inventory that will be established under the CLP Regulation.
5. Methodology for Alternative Analysis
In order to have a minimum of quality and provide some help to companies, DTSC should develop in the course of 2011 appropriate guidance in consultation with all stakeholders. The primary focus should be on health and safety aspects – i.e. comparing the hazards and exposures of the prioritised substances of concern and possible alternatives. One of the conditions for the alternatives analysis should be that none of the replacement substances can have the hazard traits identified under number (1) above, which would avoid the “replacing of one hazard with another hazard” problem. To maximise synergies with REACH, the Regulation should foresee that continuous use of a substance is only possible, if the same conditions are fulfilled as in REACH for granting authorisations: either ‘adequate control’ of all risks, or proof that the socio-economic benefits of continued use of a priority substance of concern outweigh the risks. A good starting point will be the guidance already developed by ECHA – in particular if the processes and criteria in California are aligned with those in the EU. Where necessary (e.g. to address broader aspects in the alternative analysis), DTSC should develop additional elements for guidance that are not addressed in the documents available from ECHA.
6. Oversight and Transparency
The process for the alternative analysis and monitoring the results has to be transparent and under oversight by DTSC. As a minimum, the results have to be reviewed by DTSC (or by an expert Committee nominated by DTSC – e.g. the Green Ribbon Science Panel, or by certified third parties) and preferably results should be submitted to public scrutiny, in particular in cases where companies conducting the analysis conclude that no alternatives to the prioritised substances of concern are available. Where similar claims have been refused in the EU (i.e. because alternatives are actually available) they should not be accepted in California. Necessary risk management measures identified in the alternative analysis for cases where no alternatives could be found or where adequate control could be demonstrated should be made general rules by DTSC. Where no alternatives have been found, the analysis should be repeated periodically. The draft Regulation needs to foresee clear rules on what cannot be considered confidential and/or find ways and means to allow disclosure to the public – for example in an anonymous form or by replacing very specific information (such as precise function of a chemical in a product) with somewhat broader, more generic information. The Regulation should also lay down that information on alternatives, exposures, or uses, which is easily available from the internet – including information that will be published on ECHA’s website – cannot be claimed to be confidential. Publication of the results of alternative analyses in California would provide interesting complementary information to REACH in the EU, where companies that successfully replace substances on Annex XIV do not have to report to ECHA. In order to handle the reporting and publication of the results of alternative analyses, DTSC will have to develop an appropriate IT system, which should be compatible with REACH-IT and IUCLID used by ECHA to facilitate exchange of information.
7. No Duplication with Other Regulations
Some substances and products are already regulated extensively by other State or Federal law (e.g. ozone depleting substances, food contact material, cosmetics) – they should therefore not be regulated again by DTSC in the new Regulation.
8. Direct restrictions for substances as already adopted in REACH
Annex XVII of REACH contains restrictions and/or prohibitions for a significant number of chemicals in all or some specific applications (including in consumer products) because of proven risks to human health or the environment. They are replaceable in these functions and DTSC might therefore consider adopting directly the same bans and restrictions. A similar alignment of legislation in California with EU legislation has already been established for hazardous substances in electrical and electronic equipment and for phthalates in toys. The Regulation should also foresee a restriction mechanism that DTSC can use in case of urgency or in situations where clear risks are identified without the need to wait for the results of alternative analyses conducted by companies.