Download PDF
May 1, 2011

Global Regulatory Update for May 2011

The ACTA Group


Argentina’s Senate Passes WEEE/RoHS Law: Argentina’s Senate passed on May 4, 2011, the draft Law on Minimum Standards for Management of Waste Electrical and Electronic Equipment (934/2010), which includes restrictions similar to those in the European Union (EU) Restrictions of Hazardous Substances (RoHS) Directive. The bill’s scope closely follows the ten broad product categories listed in Annex 1A of the Waste Electrical and Electronic Equipment (WEEE) Directive and includes provisions that require producers to design products that “reduce to the minimum or totally eliminate” the six substances listed in the RoHS Directive: cadmium; mercury; lead; hexavalent chromium; polybrominated biphenyls; and polybrominated diphenyl ethers. The bill must be approved by the Chamber of Deputies to become law.


ECHA Intends To Create Biocidal Products Committee: According to the European Chemicals Agency’s (ECHA) March 25, 2011, draft Multi-Annual Work Programme: 2012-2014, ECHA intends to create a Biocidal Products Committee. Under the proposed biocidal products legislation, which is currently under negotiation by the European Parliament (EP) and the EU Council, ECHA would be responsible for reviewing applications for authorization of certain biocidal products, and could, in principle, begin doing so in 2013. According to the draft document, the legislation could enter into force as early as 2012. The draft document describes the following ECHA tasks, based on the political agreement reached by the EU Council in December 2010, to implement the regulatory process:

  • Evaluation and Approval of Active Substances;
  • Evaluation and Authorization of Biocidal Products;
  • Data Sharing, Free Riders, and Technical Equivalence;
  • Register for Biocidal Products; and
  • Support to Industry.

ECHA would establish a Biocidal Products Committee that would be responsible for preparing ECHA’s opinions, in particular on applications for approval for active substances, identification of active substances that are candidates for substitution, and applications for authorization of biocidal products, including the periodical renewal of above applications. Each member state would be entitled to appoint a member to the Committee, and the modalities and operational rules of the Committee would follow very closely those of other ECHA Committees. ECHA’s draft document is available online.

Denmark Proposes Restriction Of Four Phthalates Based On Combined Exposure: Denmark submitted on April 4, 2011, an Annex XV dossier calling for the restriction of di(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), and diisobutyl phthalate (DIBP), based in part on the risks posed by the combined exposures to all four substances, based on a dose addition calculation. According to Denmark, the phthalates should be banned in articles that are for indoor use, or in articles that come into contact with skin or mucous membranes, on the grounds that they are classified as category 1B reprotoxins under the Classification, Labeling, and Packaging (CLP) Regulation. The dossier does not cover products such as toys and food contact materials. A spokesperson for the Environmental Protection Agency (MST) stated it is important the restriction is implemented even though uses of all four face the requirement of authorization because the authorization process does not apply to articles that are imported into the EU, only to those manufactured within it. DEHP, BBP, and DBP are on the authorization list, and DIBP is on the candidate list. More information is available online.

ChemSec Publishes SIN List 2.0, Targeting Endocrine Disruptors: On May 3, 2011, the International Chemical Secretariat (ChemSec) announced the addition of 22 substances, “many of them commonly found in toys, food packaging, and cosmetics,” to the Substitute It Now! (SIN) List 2.0. ChemSec selected the 22 substances of very high concern (SVHC) “solely due to their endocrine disrupting properties.” ChemSec notes that while all 27 member states have agreed under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program to limit strictly the use of SVHCs, to date, only 46 chemicals have been officially identified as SVHCs and added to the REACH candidate list. According to ChemSec, none of the 46 chemicals was selected based on endocrine disrupting properties. The 22 chemicals selected by ChemSec include:

3-benzylidene camphorEthylhexyl methoxycinnamate
4-methylbenzylidene camphorMetam natrium
4-nitrophenolMethyl tertiary butyl ether
Dicyclohexyl phthalateTert-butylhydroxyanisole
Diethyl phthalateThiram
Dihexyl phthalateZineb

EU Environment Commissioner Janez Potočnik announced during his opening speech to the annual Helsinki Chemicals Forum on May 19, 2011, that ECHA will use the list of 22 endocrine disrupting substances to select its next proposals for SVHCs to be added to the REACH candidate list. Potočnik stated: “Now is the time to innovate and to substitute these dangerous substances. The recently published second edition of the SIN List, which also includes substances with endocrine disrupting properties, should indicate to you the substances the European Commission will take into consideration for placement on the candidate list.” Potočnik refused to elaborate on his statement during a subsequent press conference. More information reading the SIN List is available online.

ChemSec And ClientEarth Sue ECHA For Release Of Companies Producing SIN List Chemicals; ECHA Says It Will Start Publishing More Information: ChemSec announced on May 9, 2011, that, together with ClientEarth, it filed suit against ECHA over its refusal to release the names of companies producing 356 chemicals included on the SIN List. ChemSec and ClientEarth first requested information on the 356 chemicals on December 1, 2010, seeking the names of manufacturers/importers, the specific tonnages, and the total tonnage bands of each substance placed on the EU market that had been registered. ECHA responded on March 7, 2011, that it would not release the requested information. ChemSec and ClientEarth specifically claim that:

  • ECHA took too long to respond to their requests and had no grounds for the delay;
  • It should have consulted the owners of the data in each case before refusing access;
  • It failed to assess whether there was an overriding public interest in releasing the data;
  • They did not provide legal arguments to show that it would harm data owners’ commercial interests to release the requested information; and
  • They should have assessed the request for each chemical on a case-by-case basis and released partial information at least where possible.

The case is being brought before the General Court of the EU.

On May 11, 2011, ECHA announced that it will begin to publish certain information from the registration dossiers that is contained in the safety data sheet (SDS), including the names of registrants. Companies will be able to keep this information confidential, “provided that a valid justification is given and accepted by ECHA.” ECHA states that registrants of hazardous substances can claim confidentiality to protect their commercial interests, provided they give a valid justification and pay the corresponding fee. ECHA will then assess the confidentiality claims. ECHA will publish the names of registrants of non-hazardous substances on a voluntary basis. According to ECHA, the extension of the information to be published “requires significant technical revisions to IUCLID and REACH-IT,” and “dissemination of the additional information cannot be released in the immediate future.” ECHA intends to make detailed information on how this information will be published and how confidentiality can be claimed “in due course.” A spokesperson for ClientEarth said it intends to proceed with its court case.

ECHA Urges Companies To Ensure That Their Registration Dossiers For Intermediates Comply With REACH: ECHA published a May 11, 2011, press release urging companies to ensure that their registration dossiers for intermediates comply with REACH. According to ECHA, after screening over 400 dossiers of substances registered as intermediates, it determined that “the majority of them do not seem to meet the conditions imposed by REACH that would justify benefiting from reduced information requirements.” ECHA “encourages registrants of intermediates to proactively reassess and, where necessary, update their registration dossiers.” Under REACH, the information that companies need to provide for certain types of isolated intermediates may be reduced, provided that the use of the substance fulfils the following two conditions:

  • The use of the substance meets the definition of an intermediate as described in REACH Article 3(15) and further explained in the Guidance on intermediates; and
  • The substance is manufactured and/or used under strictly controlled conditions.

ECHA states that, to demonstrate that a substance’s use fulfils the criteria of an isolated intermediate, a registrant should provide information on the identity of the transformation products resulting from the use of the substance and/or information on the manufacturing processes related to the registered substances. The registration dossier for an intermediate must also include sufficiently detailed information on the risk management measures describing how strictly controlled conditions are ensured, including a description of the technical means used to rigorously contain the substance. More information is available online.

ECHA Publishes Fact Sheet On SDSs And Exposure Scenarios: ECHA published a REACH fact sheet entitled “Safety Data Sheets and Exposure Scenarios: Key Information for Downstream Users.” The fact sheet states that if downstream users use hazardous substances registered under REACH, their suppliers now must provide, in most cases, a new extended SDS that includes exposure scenarios. According to ECHA, many of the 3,500 substances registered under REACH by the 2010 deadline meet the criteria to be classified as hazardous. The fact sheet recommends that downstream users take the following steps after receiving an extended SDS and registration number for a substance:

Step 1:Gather information on how the substance is used by you and your customers (if not already done);
Step 2a:Check to see whether your uses are covered in section 1.2 of the safety data sheet and in the exposure scenarios;
Step 2b:Assess if there is a clear mismatch between your uses and what is covered in the exposure scenarios —
For example: You sell your products to consumer markets, but your supplier does not cover consumer uses in the exposure scenarios.
Step 3a:If your uses are covered, compare the conditions of safe use described in the exposure scenarios with the actual conditions of use in your company and those you know about in your customers’ companies; and
Step 3b:Assess if there is a clear mismatch between your conditions of use and what is described in the exposure scenarios —
For example: The substance is contained in your product up to 20 percent, but the exposure scenario of your supplier only covers a concentration of up to 5 percent.

The fact sheet states: “If you identify a clear mismatch in step 2 or step 3 you must take action!” Possible actions include asking the supplier to include the uses in its chemical safety report and to provide a revised exposure scenario; adapting the activity to the conditions of use described in the exposure scenarios; looking for another supplier who provides an exposure scenario covering the use; and carrying out a chemical safety assessment and preparing a chemical safety report for the uses and conditions of safe use. For uses covered by the extended SDS, downstream users have 12 months to implement the measures communicated in the extended SDS and to update the SDSs for mixtures supplied further downstream. For uses not covered, downstream users have six months to report to ECHA and 12 months to carry out a chemical safety assessment and implement the related exposure scenarios. More information is available online.

ECHA Recommends Companies Prepare Now For 2013 Registrations: During ECHA’s Sixth Stakeholder Day on May 18, 2011, an ECHA spokesperson recommended that companies that have substances to be registered by the May 30, 2013, deadline should begin preparing now. Christel Musset, ECHA’s Director of Registrations, offered the following deadline calculations:

  • To achieve registration in time, companies will need to submit their individual registration dossiers from April 2013;
  • Lead registrants will need to submit their dossiers by March 30, 2013;
  • To prepare these and carry out the necessary chemical safety assessments, registrants will need to allow a year for dialogue with downstream users to establish uses and finalize chemical safety reports. Downstream users will need to inform manufacturers of their uses of substances by May 30, 2012;
  • This suggests that substance information exchange fora (SIEFs) will need to agree on substance identity, establish data needs, and decide on data-sharing arrangements by the end of 2011; and
  • Companies should make enquiries now about registered substances.

Musset urged new lead registrants to make themselves known to ECHA and reminded existing lead registrants that they have a duty to engage with new registrants to arrange data access based on fair, non-discriminatory, and proportionate arrangements, including costs. ECHA and the European Commission (EC) will hold a workshop on September 23, 2011, in Brussels aimed at potential 2013 registrants.


Japan Designates 15 Chemicals As “Special” Type I Chemicals: Effective April 1, 2011, Japan designated 15 chemicals as “special” Type I chemicals that could have an effect on fauna and flora and that must be submitted for extensive government examination before manufacture or importation. The chemicals are asbestos, ethylene oxide, cadmium and composites, hexavalent chromium, chloroethylene, dioxins, lead composites, nickel composites, arsenic and inorganic composites, 1,3-butadiene, 2-bromopropane, beryllium and composites, benzylidyne trichloride, benzene, and formaldehyde. The designation was made under the amended Chemical Substances Control Law, and the Ministry of Economy, Trade, and Industry (METI), as required by the amended Law, also revised the list of Type I chemicals classified as substances with the highest carcinogenic property, adding 167 chemicals to the category and deleting 57 substances. Type I chemicals are subject to both pollutant release and transfer and material safety data sheet (MSDS) regulations. METI also added 50 chemicals to the list of Type II chemicals, and deleted 28 chemicals. Type II chemicals are subject to the MSDS regulations requiring chemical property and safety information before delivery. METI also changed the designation of 19 Type II chemicals to Type I, and 16 Type I chemicals to Type II.


South Korea Issues Final GHS Classifications: The South Korean Ministry of the Environment (MOE) published on April 15, 2011, its final version of the list of substance classifications in accordance with the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS). A spokesperson for the MOE’s National Institute of Environmental Research stated that the list includes more than 300 of the 586 substances scheduled for compliance with the GHS regime on July 1, 2011. According to the spokesperson, South Korea began a phase-in implementation schedule on July 1, 2008. In the first phase, GHS labeling became mandatory for new chemical substances. The second phase, which will begin July 1, 2011, covers substances based on homogeneous materials. The third and final phase, which will begin July 1, 2013, will cover mixtures containing two or more different substances. More information is available in Korean online.

South Korea Updates Law Concerning Green Product Purchases: The National Assembly approved the Law on the Promotion of Green Product Purchases on March 11, 2011, and it entered into force on April 5, 2011. The Law on the Promotion of Green Product Purchases replaces the Law on the Promotion of Environmentally Friendly Product Purchases. The new Law includes provisions intended to bring green products to consumers, and includes a “green store” concept of bringing certified green products closer to consumers. Under the Law, a new labeling program will designate those stores certified as green, and green labeling qualifications will cover retail operations, from facilities and products, to management and logistics. The Law provides a legal basis for MOE’s existing program of voluntary agreements on green product procurements by industry. MOE announced on April 20, 2011, that 31 companies signed voluntary agreements on green purchasing and “committed to take the lead in promoting production, distribution and consumption of green products.” According to MOE, participating companies carry out activities to promote green purchasing, including:

  • Making and implementing green purchasing guidelines;
  • Introducing green purchasing systems; and
  • Training and publicizing green purchasing.

More information is available online.

FDA Intends To Adopt Proposed Cosmetics Labeling And Advertisement Guidelines On July 1: South Korea’s Food and Drug Administration notified the World Trade Organization on April 13, 2011, that it intends to adopt its proposed Cosmetics Labeling and Advertisement Guidelines on July 1, 2011. The Guidelines cover labeling of the containers, packages, and instruction leaflets for new products, and all advertisements for new and existing products. The Guidelines also include lists of prohibited and acceptable claims. According to the notification, the date of entry into force has yet to be determined for labeling of the containers, packages, and additional instruction leaflets for existing products.