Chemical Updates Programs

Helsinki, 8 March 2010

NEW PUBLIC CONSULTATION ON EIGHT POTENTIAL SUBSTANCES OF VERY HIGH CONCERN

The European Chemicals Agency (ECHA) has today published proposals to identify eight chemicals as Substances of Very High Concern (SVHC) and possible candidates for authorisation. The detailed proposals are available on the ECHA website using the link at the end of this press release. Interested parties are invited to comment on the eight proposals by 22 April 2010.Three EU Member States – Denmark, France and Germany have put forward proposals to identify eight chemical substances as Substances of Very High Concern (SVHC). Anyone can comment on these eight proposals within the next 45 days. Comments should focus primarily on the hazardous properties that qualify the chemicals as SVHCs. In addition, interested parties can provide comments and further information on the uses, exposures and availability of safer alternative substances or techniques. They should be aware that these aspects will mainly be considered at the next stage of the process (i.e. selection of substances for authorisation), which includes a new round of public consultation.  The Member State Committee will review these comments when seeking an agreement on the identification as SVHC before ECHA includes these substances on the Candidate List, from which substances are selected for authorisation. Substances that appear on the Authorisation List can, after a transition period, only be used if a specific authorisation is granted.  There are already 29 substances on the Candidate List. Inclusion on that list means new information requirements for suppliers of preparations and articles containing the substances.  All eight substances are proposed because of their potentially serious effects on human health. They are carcinogenic, mutagenic and/or toxic for reproduction. The names of the substances, the reasons for their proposal as SVHC and their potential uses are provided in the attached table.

CLP Regulation

New Regulation on Classification, Labeling and Packaging of Chemicals

The new EU regulation on classification, labeling and packaging of substances and mixtures, the so called CLP Regulation (EC) No 1272/2008 entered into force on 20 January 2009.

The CLP Regulation will gradually replace the Dangerous Substances Directive (67/548/EEC) and the Dangerous Preparations Directive (1999/45/EC). Both Directives will be repealed on 1 June 2015. The new regulation is based on the UN GHS of classification, labeling and packaging of chemicals. It defines a transitional period during which companies need to come into line with the new regulation:

As with the previous legislation, the CLP Regulation is intended to be primarily a self-classification system for enterprises. It stipulates that after entry into force the deadline for

  • Substance classification (according to the CLP rules) is 30 November 2010, and for
  • Mixture classification (according to the CLP rules) is 31 May 2015.

The CLP Regulation as published in the Official Journal of the European Union is available at the EURLEX website1.

New! CLP Guidance

The European Chemicals Agency has published guidance on how to comply with the provisions of the EU Regulation on classification, packaging and labelling of substances and mixtures.  See the ECHA website.2

June 17th Conference on CLP: 

The European Commission organized a conference on EU and world-wide rules for classification, labeling and packaging of chemicals. The conference aimed to inform authorities, industry and other stakeholders about the new CLP regulation in the EU, which is based on the UN GHS. It explained the main features of the new legislation, focusing on practical aspects. It provided up-to-date information on the CLP guidance documents and tools. You can access a video recording of the conference along with presentation slides on the Commission's website.3

What is CLP?

The CLP regulation will require companies to classify, label and package chemical substances and mixtures according to new rules, in addition to notifying the European Chemicals Agency (ECHA) of their classification. The new act will complement the REACH Regulation on the registration, evaluation, authorization and restriction of chemicals.

There are some implications of switching between the CLP and the two directives it replaces (Dangerous Substances and Dangerous Preparations.) Some new classification criteria will cause substances to be classified more strictly than before. The total number of classified substances will remain similar, but the total number of classified mixtures will increase under the CLP regulation.  A few substances that were not covered under DSD or DPD will be covered under CLP including certain explosives, flammable aerosols and self-heating substances. Other changes will include new pictograms, hazard statements and categories for classification.

What are the issues for U.S. companies?

  • Certain substances will be more severely classified and more mixtures will be classified
  • Companies may have to reclassify, re-label and repackage products, along with making changes to current Safety Data Sheets (SDS)
  • A change of classification under CLP can lead to new responsibilities under REACH

Harmonized classification and labeling

Under the CLP Regulation Member States may send proposals for the harmonized classification of substances that are carcinogenic, mutagenic, and toxic for reproduction or respiratory sensitizers. Industry can also in certain cases send proposals. For more information, click here4.

Notification to ECHA

The CLP Regulation requires that companies notify the European Chemicals Agency of the classification for substances. EU Importers will submit information to ECHA on behalf of U.S. exporters. Deadline for notification to the C&L inventory is: 3 January 2011.

Helpdesks

Helpdesks are to be established in each Member State to assist companies - especially SMEs - to understand their new roles and duties.

For a list of national helpdesks including detailed contact information, click here.5


Canada proposes action against decaBDE and HBCD

Industry disagrees with decaBDE debromination conclusion

September 2010


Environment Canada has published a final revised risk management strategy for polybrominated diphenyl ethers (PBDEs) following the results of a final ecological state-of-the-science report on Decabromodiphenyl ether (decaBDE), which concludes that decaBDE may accumulate to high and problematic levels in organisms, and may transform into bioaccumulative and potentially bioaccumulative substances. The brominated flame retardant industry association (BSEF) says it disagrees with some of the report's conclusions - particularly those related to debromination of decaBDE.

Environment Canada notes that a large amount of information has been published on the accumulation of decaBDE and its potential transformation to persistent and bioaccumulative products since a comprehensive risk management strategy for PBDEs was published in 2006.

In March last year the Canadian Government published a revised risk management strategy for PBDEs for a 60-day public comment period. The final revised strategy now published calls for:

  • Extension of the prohibition on the manufacture, use, sale and import currently in force for tetra-, hexa- and pentaBDE to all PBDEs assessed under the Canadian Environmental Protection Act (CEPA). As such, a ban on the use, sale and import would be extended to hepta-, octa-, nona- and decaBDE congeners, and any resin or polymer containing these substances.
  • Development of control measures under CEPA to restrict PBDEs in manufactured and imported products. While further information needs to be gathered, the intention is to prohibit the manufacture, use, sale, and import of all new products containing tetra- to decaBDE at concentrations greater than 0.1% by weight.
  • Federal Environmental Quality Guidelines for PBDEs.
  • Development of a risk management strategy for the waste sector covering landfills, incinerators and recycling facilities that will include PBDE-containing products at end-of-life.
  • Monitoring Canadians' exposure to PBDEs and concentrations in the environment.

In addition, BSEF notes that it cooperated with the Canadian authorities in the preparation of the state-of-the-science report on decaBDE. The industry group states that it does not agree with all the conclusions, in particular those drawn around the potential risk presented by debromination. In addition the group says it should be recognized that the individual members of BSEF have already established with the Canadian authorities a voluntary program to withdraw decaBDE from the Canadian market by the end of 2013.

BSEF adds: “Regarding Canada's screening assessment for HBCD and its related risk management scoping report, BSEF views these as supporting the strong case for exemptions and authorizations for its use in polystyrene insulation foams during a transition period at both UN and EU levels .”


In 2010, there were more than 700 notices of violation served; this year there have already been more than 100 notices served.California lists 4-Methylimidazole as a Proposition 65 carcinogen

Orrick Herrington & Sutcliffe LLP

On January 7, 2011, OEHHA added to the Proposition 65 list of carcinogens 4- Methylimidazole, which is used in the manufacture of pharmaceuticals, photographic chemicals, dyes and pigments, cleaning and agricultural chemicals, rubber, and in certain food products including caramel coloring, soy sauce, Worcestershire sauce, wine, and ammoniated molasses. Proposition 65, California's "Safe Drinking Water and Toxic Enforcement Act of 1986," requires the state, through the Office of Environmental Health Hazard Assessment (OEHHA), to keep a list of chemicals known to cause cancer or reproductive harm or birth defects. The list now identifies more than 800 chemicals and includes many common chemicals found in pesticides, household and industrial cleaning products, household goods, drugs, foods, and things such as tobacco smoke and wood dust.    

If a product contains a chemical on the Proposition 65 list, all businesses with ten or more employees are required to provide a “clear and reasonable warning” before exposing Californians to that product. The warning requirement, which applies to manufacturers and retailers alike, becomes effective one year after the chemical is placed on the Proposition 65 list. This means that unless the listing of 4-Methylimidazole by OEHHA can be successfully challenged in the courts or a business can establish an exemption to the warning requirement, all products containing 4-Methylimidazole will be required to carry Proposition 65 compliant warning no later than January 7, 2012.1

Proposition 65 Compliance

In order for a warning to be Proposition 65 compliant, the following considerations must be satisfied:  

  • The Warning Must Be “Clear.” The text of the warning must communicate that the chemical is known to cause cancer, or reproductive harm. The regulation provides the following safe-harbor “clear” warning language for a carcinogen:  

   WARNING: This product contains a chemical known to the state of California to cause cancer, or birth defects or other reproductive harm.  

  • The Warning Must Be “Reasonable.” The warning must be conspicuous enough that a consumer would probably see it before the exposure. If it appears on a label with other warnings, it must be no smaller than the other warnings. The other language should not contradict the warning language. Further, any language included in the warning, elsewhere on the warning label and/or elsewhere on the product that somehow softens the warning will likely be determined to fall outside the safe harbor.  

Proposition 65 Exemptions

A business has “safe harbor” from Proposition 65 warning requirements if exposure to a chemical occurs at or below the no significant risk level NSRL.2 The NSRL is defined as the level of exposure that would result in not more than one excess case of cancer in 100,000 individuals exposed to the chemical over a 70-year lifetime. In other words, a person exposed to the chemical at the “no significant risk level” for 70 years would not have more than a “one in 100,000” chance of developing cancer as a result of that exposure. OEHHA has proposed an NSRL for 4-Methylimidazole of 16 micrograms per day.3 Although OEHHA has proposed the NSRL, it is unlikely that OEHHA will adopt an NSRL for 4-Methylimidazole within the next year.  

As a practical matter, even if an NSRL is established for 4-Methylimidazole, it may be difficult for a business to establish that the 4- Methylimidazole in its product falls within the NSRL. Proposition 65 compliance is based on how much of a substance the average person is exposed to, not on how much is in the product. For exposures to consumer products, lifetime exposure must be calculated using the average rate of intake or exposure for average users of the consumer product, and not on a per capita basis for the general population. The average rate of intake or exposure must be based on data for use on a general category or categories of consumer products, such as the United States Department of Agriculture Home Economic Research Report, Foods Commonly Eaten by Individuals: Amount per Day and per Eating Occasion.

Proposition 65 Remedies and Enforcement

The primary remedies available under Proposition 65 are injunctions and civil and criminal penalties of up to $2500 per violation per day. Proposition 65 is enforced through litigation brought either by "public enforcers" (including the California Attorney General and certain district attorneys) or by "citizen enforcers" (organizations or private Californian citizens). Most Proposition 65 actions are filed by citizen enforcers.

Since 1986, few Proposition 65 cases have been fully litigated through trial. Of note, it was an Orrick, Herrington & Sutcliffe attorney who recorded the first trial win in a Proposition 65 case against the California Attorney General. The vast majority of the cases have been settled out of court or resolved through consent judgments. Citizen enforcers collect millions of dollars in settlements from manufacturers and retailers every year. Not surprisingly, the number of Proposition 65 cases filed each year continues to increase. In 2010, there were more than 700 notices of violation served; this year there have already been more than 100 notices served. The majority of the notices have been directed to businesses manufacturing or selling household goods, accessories, personal care products and foods and nutritional supplements.


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