Global Regulatory Update for May 2016
MIIT Publishes FAQs On China RoHS2: On May 16, 2016, the Ministry of Industry and Information Technology (MIIT) announced the availability of FAQs on the Administrative Measures for the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products (China RoHS2). According to the FAQs, products that are excluded from the scope of China RoHS2 include power generation, transmission, and distribution equipment; electric transportation devices; products for military uses; products for special circumstances or extreme conditions; export products, including components imported into China to manufacture products intended for export; second-hand products; packaging materials; sample products for research and development (R&D) or exhibition but not for sale; and electrical and electronic parts (EEP) intended for non-electrical and electronic products, for example, monitors intended for airplanes or automobiles and components for power generators. There are 56 questions in the FAQs, including a decision tree for EEPs under the scope of China RoHS2 and a flow chart of the process and timeline for the implementation of China RoHS2. The FAQs address how to calculate the Environmental Protection Use Period (EPUP) and indicate it on the product; the transition period for the implementation of China RoHS2; and whether manufacturers or component suppliers are responsible for non-compliant products. China RoHS2 expanded the coverage of the Regulation from electronic information products (EIP) to EEPs, defined as devices and accessory products with a voltage rating not exceeding 1,500 Volts (V) for direct current and 1,000V for alternating current that function by means of current or electromagnetic fields and generate, transmit, and measure such currents and electromagnetic fields. China RoHS2 restricts the following substances according to the national standard GB/T 26572-2011 “Requirements of Concentration Limits for Certain Restricted Substances in [EEPs],” which are the same as those restricted by the European Union (EU):
- Cadmium and its compounds: 0.01%;
- Mercury and its compounds: 0.1%;
- Lead and its compounds: 0.1%;
- Hexavalent chromium and its compounds: 0.1%;
- Polybrominated biphenyls: 0.1%; and
- Polybrominated diphenyl ethers: 0.1%.
The above maximum control values apply to each homogenous material rather than a product itself. The limits apply only to products listed in the Compliance Management Catalog, which has not yet been published. The Compliance Management Catalog will be published in batches with certain exemptions, and there will be a transition period for the implementation of the Compliance Management Catalog after it is published. Non-listed products or parts that contain certain hazardous substances exceeding the above limits may still be sold in China provided that the products are marked and the names and content of the hazardous substances are disclosed according to the electronics industry standard SJ/T 11364-2014 “Marking for the Restricted Use of Hazardous Substances in [EEPs].” The marking on EEP components intended for after-sales services of the product, however, is not required. More information on RoHS2 is available in our January 28, 2016, memorandum, “China Publishes Long Awaited RoHS2 Regulation.”
EPA Reviews List Of “Undesirable” Substances: The Danish Environmental Protection Agency (Danish EPA) announced on April 28, 2016, that a quarter of the substances on its List of Undesirable Substances (LOUS) do not require any additional action. The Danish EPA conducted surveys and collected information on the 40 substances and substance groups on the list. It is now preparing substance evaluations for:
- Tetrabromobisphenol A (TBBPA), a widely used flame retardant. The Danish EPA stated that this is a potential endocrine disruptor and is suspected to be persistent, bioaccumulative, and toxic (PBT).
- Phenols that are used as solvents in products such as adhesives, paints, and coatings. The Danish EPA expressed that these are suspected mutagens and can potentially cause other system toxicity through repeated exposure.
- 2,3- epoxypropylneodecanoate (EPDA), a paints and varnishes binding agent, on the grounds that it is a suspected carcinogenic, mutagenic, and reprotoxic (CMR) substance and suspected sensitizer.
- Bisphenol A diglycidyl ether (BADGE); the Danish EPA stated this is a potential endocrine disruptor and is suspected to be CMR.
The Danish EPA will evaluate Tris (chloroisopropyl) phosphate (TCPP), a flame retardant used in flexible foam for furniture and insulation in buildings, in 2017. The Danish EPA will conduct this evaluation on the basis that TCPP is a potential endocrine disruptor, and is suspected to be CMR and PBT. The Danish EPA’s plans for improvement to the LOUS project include making surveys more uniform with clearly-defined conclusions and extending deadlines for public hearings.
Further information is available, in Danish, in the Danish EPA’s press release “Bedre styr på den uønskede kemi.”
Minister Larsen Wants EU-Wide Ban On Microplastics In Cosmetics: Esben Lunde Larsen, Denmark’s Environment and Food Minister, has encouraged the European Commission (EC) to introduce a ban on microplastics in cosmetics across the EU. In the Danish Ministry of Environment and Food’s May 6, 2016, press release, “Esben Lunde Larsen opfordrer EU til forbud mod mikroplast i kosmetiske produkter,” Minister Larsen expresses, in Danish, that microplastics from cosmetic products can make their way into the aquatic environment, and eventually into the food chain. Minister Larsen provides in the press release that the spread of microplastics should be limited and that suitable alternatives exist. The press release refers to the U.S.’s recent ban on the use of microplastics in cosmetics (e.g., toothpastes), which takes effect in 2017, and expresses a need for similar measures in Europe. The press release states that a single body scrub may contain 500,000 pieces of microplastic and highlights concerns for fish and birds in this regard.
More information is available in the Danish EPA’s 2015 report, “Microplastics – Occurrence, effects and sources of releases to the environment in Denmark.”
SCHER States Limit Values For Toys Are Safe: On April 8, 2016, the EC’s Scientific Committee on Health and Environmental Risks (SCHER) adopted by written procedure a “Final Opinion on Estimates of the Amount of toy materials ingested by children.” The EC asked SCHER to review available data on the ingestion of three types of toy material by children to evaluate if the current ingestion amounts, derived from the Dutch National Institute of Public Health and the Environment’s (RIVM) 2008 report, are still appropriate.
The SCHER concluded upon evaluation of available data that the existing limits are still appropriate, indicating that “[o]nly one study providing new data on mouthing [behavior] related to toys and one meta-analysis on studies before 2009 on object-to-mouth frequency data were published.” The SCHER recommendation accounts for a wide variety of toys, the differences in mouthing behavior, the high frequency of toy mouthing in young children, and the gaps in available information.
The current estimated ingestion amounts are:
- 100 milligrams per day (mg/d) of dry, brittle, powder-like, or pliable toy material;
- 400 mg/d of liquid or sticky toy material; and
- 8 mg/d of scraped off toy material.
ECHA Develops New Online Tools For Submitting Information To Poison Centers: On April 11, 2016, the European Chemicals Agency (ECHA) announced that, under a draft Classification, Labeling, and Packaging (CLP) implementing regulation, importers and downstream users placing hazardous mixtures on the market will be responsible for submitting information to poison centers in the relevant Member States. Once the draft implementing regulation is adopted, the deadlines for the submissions will apply in a stepwise manner and they will depend on the intended use of the mixture. According to ECHA, a distinction will be made between mixtures for consumer use, professional use, and industrial use. The draft format for the submission of harmonized information, together with a draft online application, is available on the new poison centers website hosted by ECHA. The draft tool and format enable companies and Member State competent authorities to prepare for the submission of information to the poison centers. ECHA states that it will update the draft tool and format later in 2016 when the implementing regulation is expected to enter into force. More information is available in ECHA’s press release, “New online tools for submitting information to poison centres.”
EP Supports Trade Secrets Directive: On April 14, 2016, the European Parliament (EP) issued a press release entitled “Trade secrets: protecting businesses, safeguarding the right to information.” The press release indicates that the EP has adopted the EC’s proposal for a Trade Secrets Directive. Rapporteur Constance Le Grip stated “[w]ith one company out of every five a victim of theft of trade secrets every year, [harmonization] should allow the creation of a safe and trustworthy environment for European companies, which will see their intangible assets and know-how secured.”
The Directive, informally agreed with ministers before the vote, introduces an EU-wide definition of “trade secret,” which includes “information which is secret, has commercial value because it is secret, and has been subject to reasonable steps to keep it secret.” Under the Directive, EU Member States are required to ensure that victims of misuse of trade secrets are able to defend their rights in court and seek compensation. The agreed upon text also provides rules to protect confidential information in legal proceedings.
In negotiations with ministers, Members of the EP emphasized the need to ensure that the legislation does not curb media freedom or restrict the work of journalists, particularly relating to their investigations and the protection of their sources.
The Directive has received mixed feedback from stakeholders. The European Chemical Industry Council’s (Cefic) press release on the issue welcomed the Directive, stating that trade secrets “are an intangible asset of crucial importance to [Small- and Medium-Sized Enterprises (SME)] in Europe.” In contrast, David Azoulay of the Center for Environmental Law (CIEL) stated “n the context of chemical regulation implementation, [the Directive] is likely to encourage industry malpractices and will undoubtedly reinforce the large number of unfounded claims for confidential business information, at the expense of citizens’ rights to information.”
BPC Adopts Opinions On Six Active Substances: ECHA announced on April 18, 2016, that its Biocidal Products Committee (BPC) has adopted 15 opinions supporting the approval of six active substances for use in biocidal products used for human and veterinary hygiene, and as preservatives.
- Chlorocresol for use in human hygiene disinfectants (product-type 1); disinfectants and algaecides not intended for direct application to humans or animals (product-type 2); veterinary hygiene products (product-type 3); preservatives for products during storage (product-type 6); fibre, leather, rubber, and polymerized materials preservatives (product-type 9); and working or cutting fluid preservatives (product-type 13).
- Coco alkyltrimethylammonium chloride (ATMAC/TMAC) for use in wood preservatives (product-type 8).
- Burnt lime, hydrated lime, burnt dolomitic lime, and hydrated dolomitic lime for product-types 2 and 3.
The BPC concluded that these substances in the relevant product-types may be approved. The adopted opinions will serve as the basis for final decision-making by the EC and Member States. Approval of an active substance is granted for a defined number of years, not exceeding ten years.
More information is available in ECHA’s press release, “Biocidal Products Committee adopts opinions on six active substances,” and in the related Annex.
REACH Committee Approves DEHP Use And Supports BPA Restriction: On April 20, 2016, the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Committee approved a proposal by the EC to grant authorization to three companies to use Di(2-ethylhexyl)phthalate (DEHP) in recycled soft polyvinyl chloride (PVC)-containing articles. Most Member States supported the draft decision, which imposes strict conditions on Vinyloop Ferrara, Stena Recycling, and Plastic Planet for the companies to reapply for authorization until 2019. The controversial draft decision requires downstream users to make monitoring and biomonitoring information available to ECHA before the end of 2016. The European Environmental Bureau (EEB) provides in an April 15, 2016, letter to members of the REACH Committee that the draft decision breaches the REACH Regulation because the risks related to the uses of DEHP are not adequately controlled; there are suitable alternative substances and technologies; and the applicants did not demonstrate that the socio-economic benefits of continued use outweigh the risks to human health or the environment.
The REACH Committee also discussed the restriction of the use of Bisphenol A (BPA) in thermal paper. France had previously proposed a ban on the use of BPA in thermal paper to reduce exposure to the general population and particularly to cashiers. ECHA’s Committee for Risk Assessment (RAC) generally agreed with France’s conclusions, however, it disagreed with the approach used by France to calculate risks. The proposal and related Annex, restricting placing on the market of thermal paper containing BPA in concentrations equal to or greater than 0.02 percent by weight, were supported by most countries present at the REACH Committee meeting. The EC has submitted the proposal to the World Trade Organization and the proposed timeframe for adoption is the second half of 2016. Application of the proposal would be deferred for three years to allow industry to comply effectively with the requirements.
REACH Committee Approves Annex Amendments For Skin Sensitization: At the April 20, 2016, meeting of the REACH Committee, Member States voted to approve amendments to revise data requirements for skin sensitization. The draft amendments to REACH Annex VII provide that an in vivo study should be conducted only if in vitro and/or in chemico test methods are not applicable, or if the test results are not adequate for risk assessment. In such scenarios, the amendments state that a murine local lymph node assay (LLNA) should be used.
The amendments require that in vitro and in chemico tests address the following skin sensitization events:
- Molecular interaction with skin proteins;
- Inflammatory response in keratinocytes; and
- Activation of dendritic cells.
Further information is available in the Agenda for the “Meeting of the REACH Committee of 20 April 2016.”
EC Publishes Data On Dangerous Products: On April 25, 2016, the EC published data indicating that in 2015, more than 2,000 dangerous products triggered EU-wide alerts. The EC stated that “n 2015, toys (27%) and clothing, textiles and fashion items (17%) were the two main product categories for which corrective measures had to be taken. These were already the most notified products the year before. As far as risks are concerned, in 2015, the most frequently notified risk (25% of the total of the notifications) was chemical risk, followed by the risk of injuries (22%), which was at the top of the list in the previous report.”The EC provided that the most frequent chemical risks notified in 2015 related to fashion jewelry with harmful heavy metals (e.g., nickel and lead) and toys containing phthalates. Sixty-two percent of the total notified dangerous products originated in China. The EC stated “[c]ollaboration with the Chinese authorities continues to be a priority for the EU and, more specifically, takes place within the Rapid Alert System China mechanism: each notification concerning a product of Chinese origin is sent to the Chinese administration, so that they address the issue with the manufacturer or exporter directly if these economic operators are traceable.” China has followed up on over 11,000 notifications to date, and has implemented corrective measures in over 3,000 cases.These data were published by the EC through use of the Rapid Alert System that seeks to ensure information regarding dangerous non-food products withdrawn from the market and/or recalled anywhere in Europe is circulated swiftly among Member States and the EC. Thirty-one countries currently participate in the Rapid Alert System.More information is available in the EC’s press release, “Protecting European consumers: toys and clothing top the list of dangerous products detected in 2015.” Additional detail is available in the report for 2015, “Rapid Alert System for Dangerous Products – 2015 Results,” and in the associated main results factsheet.NGOs Address Position On TTIP: On April 25, 2016, the Health and Environment Alliance (HEAL), CIEL, EEB, and ClientEarth wrote to Cecilia Malmström, the EU Trade Commissioner, urging the exclusion of the “Good Regulatory Practices” chapter from the EC’s Transatlantic Trade and Investment Partnership (TTIP) proposals. The non-governmental organizations (NGO) stated “the aims of the ‘Good Regulatory Practices’ chapter are to limit the impact of regulatory measures on transatlantic trade. The impact will, however, be the largest in areas where there are high levels of variation between EU and US legislation and standards such as the chemicals sector. As a result the EU’s ability to adopt and implement regulation will be affected most heavily in these areas.”The NGOs stated that it is important to “ensure that controversial elements of the EU’s ‘Better Regulation’ agenda are not embedded in a legally binding trade agreement.” The letter reminded Ms. Malmström of the EP’s July 2015 resolution on TTIP, which provided that TTIP should not affect standards “that have yet to be set in areas where the legislation or the standards are very different in the US as compared with the EU, such as, for example, the implementation of existing (framework) legislation (e.g. REACH) […] or future definitions affecting the level of protection (e.g. endocrine disrupting chemicals).”The letter references a report entitled “Better Regulation – TTIP under the Radar?,” published by Forum Umwelt Entwicklung, Bread for the World, and EEB. HEAL and CIEL are coordinating a campaign, “TTIP: Private profit versus public health,” that addresses their various concerns with TTIP. The campaign wants to “[t]ake chemicals out of the EU-US trade talks” and highlights differences between EU and U.S. chemical regulations.ECHA Will Publish More Information From REACH Registrations: On April 25, 2016, ECHA issued a press release announcing that, at the end of June 2016, it will publish on its website additional information from companies’ registrations, such as endpoint summaries, exposure scenarios, and new elements introduced by IUCLID 6. ECHA states that the publication of this information will start from new and updated dossiers only. At a later stage, ECHA will also publish the information from old submissions. According to ECHA, the endpoint summaries indicate the study results that are considered most relevant to perform a chemical safety assessment for a given endpoint. ECHA intends the publication of these summaries to enable registrants to highlight key results in the brief profile of their substance. ECHA will also start publishing information on exposure scenarios, including the conditions for safe use. ECHA notes that companies that would like to request confidentiality on their exposure scenarios need to review their dossiers before submitting an update. ECHA will make available information on other identifiers in section 1.1 of IUCLID if not requested confidential. ECHA will now always publish the reliability score of a study. In addition, according to ECHA, it will publish some information from the new elements introduced in IUCLID 6, including:Assessment entities;
New composition types, including boundary compositions;
Nanoforms of registered substances; and
Justification for providing a reduced set of information requirements (Annex III).ECHA will publish the additional registration data in phases. ECHA states that, from the go-live of REACH-IT (June 21, 2016), any new or updated dossier submitted to ECHA will have this data published. After the 2018 registration deadline, any dossiers that have not been updated will be reprocessed to publish this data. With this approach, ECHA intends to minimize the burden on industry, for example, by avoiding large scale updates to address potential confidentiality concerns. More information is available in ECHA’s press release “More information to be published from REACH registrations.”NGOs Call For Actions, Not Words, From The EC On Nanotechnology: On April 26, 2016, a group of NGOs, consumer groups, and research organizations issued a press release entitled “Civil society demands action, not words, on nanotechnology,” expressing “disappointment with the European Commission’s continuing failure to propose adequate measures for the collection and publication of information about nanomaterials on the EU market after a Commission meeting with stakeholders in Brussels on Monday.” The press release criticizes the EC for deciding against an EU-wide nanomaterial registry before completing the impact assessment process. Instead, according to the press release, the EC asked ECHA to develop a nanomaterial observatory as part of its 2015-18 nanomaterials work plan. The press release states that the April 25, 2016, meeting “was supposed to provide more details about this new mechanism, but in reality it provided little hope that the observatory will be able to address the pressing information gaps about nanomaterials on the market.” As reported in our April 2016 Global Regulatory Update, during the March 10-11, 2016, meeting of the Competent Authorities for REACH and CLP (CARACAL) Subgroup on Nanomaterials (CASG Nano), the EC informed Member State officials that its preferred option for improving transparency on nanomaterials is a public website listing existing information, rather than an EU register. ECHA will develop the website to provide existing information on nanomaterials. ECHA stated that different sections of the website “may have different key audiences,” and that it faces a unique challenge to present information in a user-friendly way for consumers.EP Issues Report On FCMs: On April 26, 2016, the EP’s Committee on the Environment, Public Health and Food Safety issued a “Draft Report on the implementation of the [Food Contact Materials (FCM)] Regulation (Regulation (EC) No 1935/2004) (2015/2259(INI)).” The draft report addresses a number of issues, including varying approaches towards enforcement among Member States. In this regard, the report states “the specific measures adopted by one Member State at national level, may differ from those of another Member State, creating different standards for product safety. … Complying with different national rules is neither efficient nor effective in achieving the objectives of the legislation.” The report emphasizes the importance of Member States regulating companies that produce or import FCMs, and states regretfully that “some Member States do not impose the requirement for companies to register their business activity, thereby allowing such companies to circumvent conformity controls.”Regarding “[t]raceability,” the draft report states that a Declaration of Compliance (DoC) can be an effective tool to ensure that FCMs are compliant with the relevant rules. The report recommends that all FCMs, harmonized or non-harmonized, should be accompanied by a DoC and other appropriate documentation. The draft report states that currently, “even when they are mandatory,” DoCs are not always available for enforcement purposes.The draft report recognizes the European Food Safety Authority’s (EFSA) importance in the risk assessment of substances used in FCMs and acknowledges EFSA’s limited resources. To this end, the report recommends that EFSA should receive increased funding. The report “[r]egrets that EFSA, in its current risk assessment procedure, does not take account of the so-called ‘cocktail effect’ or multiple exposures, and urges EFSA to do so in future.” The aforementioned cocktail effect refers to the impact of chemicals with similar toxicological endpoints acting together.The draft report emphasizes the challenge presented by non-intentionally added substances and “[c]alls on the Commission to ensure better coordination between REACH and FCM legislation, especially as regards substances classified as SVHCs under REACH.” The importance of EU-level development and harmonization of regulations for FCMs is emphasized unequivocally in the draft report.Members of the EP are required to submit any comments on the draft report by June 1, 2016.ECHA Begins Public Consultations On Applications For Authorizations: ECHA announced on April 27, 2016, that it has launched public consultations on 29 applications for authorization covering 47 uses of:Chromium VI compounds used in surface treatment, hard chrome plating, conversion coating, passivation, and cooling systems. These uses take place in various industry sectors such as chemical industry, metal and mechanical industry, armament, aerospace, automotive, electronics, and lithography;
1,2-dichloroethane (EDC) used as solvent in the production of biocides/pesticides, active pharmaceutical ingredients, paraffin waxes, and polymers. Used as a swelling agent in the manufacture of ion exchange resins;
Bis(2-methoxyethyl) ether (Diglyme): Used as a carrier solvent in an etchant for fluoropolymer surface modification, and in the manufacture of active pharmaceutical ingredients. Used as a processing aid in the manufacture of a chemical. Used as a process chemical in the manufacture of Dynabeads®; and
Formaldehyde, oligomeric reaction products with aniline (Technical MDA): Used in an epoxy resin hardener.More information about the uses for which authorization is applied, including the description of the function of the substance, exposure scenarios, possible alternatives identified by the applicants, together with socio-economic information, is available on ECHA’s website. Comments are due June 22, 2016.Cefic Launches AMBIT Software: Cefic has officially launched AMBIT, a software tool designed under its Long-Range Research Initiative (LRI) to assist companies in complying with chemical regulations by using read-across principles. ECHA has provided the LRI project access to the entire non-confidential REACH dataset, consisting of several thousand substances. By using AMBIT, unknown chemical properties can be predicted from those that are known of similar compounds through a large database and various modules. AMBIT includes more than 450,000 chemical structures and their identifiers (e.g., Chemical Abstracts Service (CAS) Numbers). Users can access a wide range of existing information on a chemical and securely upload data generated by their companies.More information is available in Cefic’s press release, “Cefic launches ‘AMBIT’ chemical safety prediction software.”Greenpeace Leaks Controversial TTIP Documents: On May 2, 2016, Greenpeace Netherlands “leaked” several confidential documents related to the 13th round of TTIP negotiations. Greenpeace Netherlands announced its intention to make these documents publicly available in a May 1, 2016, press release entitled “Leaked TTIP documents confirm major risks for climate, environment and consumer safety.” In its press release, Greenpeace Netherlands makes a number of assertions, including that “[h]ard won environmental progress is being bartered away behind closed doors” and “civil society was right to be concerned about TTIP.” Greenpeace Netherlands indicates that, under TTIP, the following issues are of “serious concern” from an environmental and consumer protection point of view: (i) “Long standing environmental protections appear to be dropped” as the General Agreement on Tariffs and Trade (GATT) General Exceptions Rule has not been incorporated; (ii) “Climate protection will be harder under TTIP” as it is not addressed sufficiently; (iii) TTIP may be “[t]he end of the precautionary principle” as it is not mentioned in the chapter on Regulatory Cooperation whereas the U.S. “risk based” approach is present in various chapters; and (iv) TTIP “[opens] the door for corporate takeover,” partly due to insufficient consultation with “civil society.”Greenpeace Netherlands’ stance on the leaked documents is echoed by the International Chemical Secretariat (ChemSec) in its May 2, 2016, press release, “Leaked TTIP documents reveal ambitions to lower environmental protection.” Theresa Kjell, ChemSec’s Senior Policy and Business Advisor, states “[t]he leaked documents indicate that the fears of a lower level of protection and even an abandonment of the precautionary principle are actually well founded. This is clearly not the type of trade deal neither progressive companies, nor the people of Europe, can accept. Both context and openness should have been different, and now it is difficult to see how these negotiations could continue.”The EC responded to the leak by stating that the documents made available provide current positions and are far from final. In this regard, Cecilia Malmström provides in her May 2, 2016, blog post entitled “Negotiating TTIP” that “t is only normal that both parties in a negotiation want to achieve as many of their own objectives as possible. That does not mean that the other side gives in to those demands. That does not mean that the parties will meet halfway. In areas where we are too far apart in a negotiation, we simply will not agree. In that sense, many of today’s alarmist headlines are a storm in a teacup.”Ms. Malmström states “t begs to be said, again and again: No EU trade agreement will ever lower our level of protection of consumers, or food safety, or of the environment. Trade agreements will not change our laws on [genetically modified organisms], or how to produce safe beef, or how to protect the environment … I am simply not in the business of lowering standards. I have a clear negotiating mandate for the negotiations given to the Commission by 28 EU governments, that clearly spells out what a successful agreement has to look like, and what our non-negotiable red lines are. And as always, the end result of a negotiation would have to be cleared by those 28 Member States and the [EP] before becoming reality.”Ignacio Garcia Bercero, the EC’s Chief Negotiator on TTIP, stated that allegations that the precautionary principle is not being protected in TTIP negotiations, or that TTIP will override the GATT General Exceptions Rule, are “flatly wrong.” Mr. Bercero stated “[o]ur position is very clear: We will not agree on anything that implies lowering the level of protection. Full stop. That’s our position and the Americans know it perfectly well.”More information is available in the “TTIP Leaks” by Greenpeace Netherlands.Motion Of Censure On EC For Endocrine Disruptors Lapses: On May 12, 2016, EP Vice President Ryszard Czarnecki announced that Members of the EP called for a motion of censure on the EC because it had not complied with its legal obligation to publish scientific criteria for defining endocrine disruptors. The widely supported motion was drafted by Piernicola Pedicini of the Europe of Freedom and Direct Democracy group.As reported in our January 2016 Global Regulatory Update, the General Court of the EU ruled on December 16, 2015, that the EC had “breached EU law” by failing to publish scientific criteria for defining endocrine disruptors as a first step towards reducing exposure to them. In a March 2013 resolution, the EP urged the EC to take measures to reduce exposure to endocrine disruptors because of recent increases in cases of impaired sperm quality, early onset of puberty, “certain cancers,” and other disorders.According to Rule 119 of the Rules of Procedure of the EP, a motion of censure on the EC may be submitted to the President of the EP by one-tenth of the component Members of the EP. The EP is required to debate this motion in a plenary session, at least 24 hours after it is announced. It is then put to a roll-call vote, at least 48 hours after the beginning of the debate. To be adopted, the motion of censure needs to secure a two-thirds majority of the votes, representing a majority of the component Members of the EP.On May 19, 2016, the EP announced that 16 Members of the EP withdrew their signatures from the motion of censure, causing the motion to lapse as the minimum number of required signatures is no longer met. The “procedure is closed” for this motion of censure.More information is available in the EP’s press releases, “Endocrine disruptors: motion of censure on the Commission announced in plenary” and “Endocrine disruptors: motion of censure on the Commission lapsed.”EC Proposes Enhanced Protection Against Carcinogens; ChemSec Criticizes Proposed OEL For Hexavalent Chromium: In a May 13, 2016, press release, “Commission proposes better workers’ protection against cancer-causing chemicals,” the EC stated “[c]ancer is the first cause of work-related deaths in the EU, accounting for 53% of the total and therefore the single biggest health risk to workers in the [EU].” For this reason, the EC proposed new or amended occupational exposure limits (OEL) for the following 13 chemicals under the Carcinogens and Mutagens Directive (2004/37/EC):1,2- Epoxypropane — 2.4 milligrams per cubic meter (mg/m3);
1,3-Butadiene– 2.2 mg/m3;
2-Nitropropane — 18 mg/m3;
Acrylamide — 0.1 mg/m3;
Bromoethylene — 4.4 mg/m3;
Chromium (VI) compounds — 0.025 mg/m3;
Ethylene oxide — 1.8 mg/m3;
Hardwood dusts — 3 mg/m3;
Hydrazine — 0.013 mg/m3;
o-Toluidine — 0.5 mg/m3;
Respirable crystalline silica — 0.1 mg/m3;
Refractory ceramic fibers — 0.3 fibers per milliliter (f/ml); and
Vinyl chloride monomer — 2.6 mg/m3.The EC stated that the proposal can help reduce health care costs, lost earnings, and other costs for persons affected and for caretakers. Furthermore, the EC indicates that the proposal can provide a “compliance benchmark,” benefit businesses significantly, and assist Member States in managing health care, administrative costs, and legal costs. More information is available in the “Fact Sheet” issued by the EC.On May 19, 2016, ChemSec criticized the proposed OEL for hexavalent chromium as “a level of exposure that will have huge effects on the workers as well as anybody living close to facilities where it is used.” ChemSec notes that many countries allow for a considerably lower level of exposure — for example, the limit in France is 1 microgram per cubic meter (μg/m3), while in Sweden, Lithuania, and Denmark, the limit is 5 μg/m3. According to ChemSec, the proposed OEL could also “open up a possibility for companies to use this chemical without having to apply for authorisation, which is the case today.” ChemSec states that under REACH Article 58.2, companies do not need authorisation if the chemical is regulated under an equivalent legislation. ChemSec claims that “[s]ome argue that the OEL for Chromium VI under the workers protection legislation could qualify as equivalent to REACH with regard to human health.”ECHA Publishes Annex III Inventory: On May 18, 2016, ECHA announced that it has published an inventory of substances that “helps REACH registrants, who manufacture or import between 1 to 10 tonnes per year, in deciding whether they may be able to register their substance with limited information.” The reduced information requirements include only physicochemical properties.ECHA provides that the reduced requirements can only be used if Annex III criteria do not apply. This means that a reduced set of information is applicable if:There is no indication that a substance is likely to have CMR (category 1A or 1B), PBT, or very persistent and very bioaccumulative (vPvB) properties; or
There is no indication that a substance with dispersive or diffuse uses would be classified as hazardous for human health and/or as an environmental hazard under the CLP Regulation.ECHA provides that if a substance meets Annex III criteria, a full set of information, including physicochemical, toxicological, and ecotoxicological information, is needed. ECHA states that “[t]he Annex III inventory helps you to decide which set of information is necessary for your registration. You can search the inventory to find out whether your substance is likely to fulfil any of the Annex III criteria, and needs to be registered with the full set of data. However, even though your substance appears in the inventory, you may still benefit from the reduced requirements. In this case, you will need to gather further information and give a justification in your registration dossier.” ECHA has provided advice on how to use the inventory and states that registrants “can make [their] case for not meeting the Annex III criteria in a new template in IUCLID 6.”More information is available in ECHA’s press release, “New support for companies registering low tonnage, low risk chemicals.”EC Issues Evaluation And Fitness Check Roadmaps: On May 18, 2016, the EC issued fitness check roadmaps for REACH and chemicals legislation excluding REACH. The fitness checks are part of the EC’s REFIT program, which seeks to determine whether current regulatory schemes are achieving their goals. In accordance with REFIT, both roadmaps address “effectiveness,” “efficiency,” “coherence,” “relevance,” and “EU added value.”The REACH fitness check roadmap addresses the EC’s obligation to report on the functioning of REACH every five years and provides that there is a legal obligation for the EC to report by June 1, 2017. The roadmap states that “Article 138 of REACH further specifies some elements that are relevant for the report,” and provides that other detailed topics to be covered will include assessment of the benefits of chemical legislation on human health and the environment; assessment of the achievements made regarding the use of alternative test methods and non-test methods in REACH and in general; perception of chemical safety by citizens; and consideration of substance identity issues.The roadmap for chemical regulations excluding REACH provides an expansive “non-exhaustive list” of legislation within its scope. This includes the CLP Regulation, the Plant Protection Products Regulation, and numerous other Regulations and Directives relating to worker safety, environmental protection, chemical control, and product control.ECHA Publishes List Of Guidance Documents Still To Be Updated: ECHA published on May 23, 2016, a list of the REACH guidance documents that are or will be under consultation, and thus are not part of the two-year moratorium beginning May 31, 2016. The list shows the status of the documents and when ECHA expects to publish the final version. ECHA states that draft guidance documents under consultation are available on its website and “give an idea of the upcoming changes. Thus, they can already be useful to potential registrants for the 2018 deadline.” More information is available in ECHA’s press release, “Check which REACH guidance will still be updated.”GERMANYUBA Publishes Microplastics Report: The Federal Environment Agency (UBA) has issued a report on microplastics in the environment. Microplastics are small plastic fragments created when plastics are degraded by physical, chemical, and microbial processes. The report includes, due to “[t]he absences of scientifically reliable statements,” a “comprehensive overview” of scientific papers on microplastics inputs, microplastics sources, and microplastics’ induced effects in aquatic systems. The efficacy of varying sampling techniques, sample preparations, and microplastics detection procedures is also addressed in the report.The report relies on studies analyzing the microplastics content of several German rivers and lakes for aquatic assessment values. Additionally, a study analyzing the microplastics input of municipal wastewater treatment plants in northern Germany “leads to the wastewater assessment” in the report.The report provides guidelines for managing the classification and interpretation of microplastics sample values, and addresses microplastics in light of national and international legal systems. As “[o]ne pillar of the EU’s Water Framework Directive is to take precautionary measures to prevent possible environmental damage,” the report closes with proposals to limit “microplastics input.”More information is available, in German, in “Mikroplastik: Entwicklung eines Umweltbewertungs konzepts.” An English summary is available on page seven of the report.BfR Publishes Workshop Report Based On The Expert Meeting On Endocrine Disruptors: The Federal Institute for Risk Assessment (BfR) announced on May 4, 2016, the availability of a workshop report based on the April 11-12, 2016, expert meeting on endocrine disruptors organized by BfR. The consensus statement, included in the report “Scientific principles for the identification of endocrine disrupting chemicals — a consensus statement,” states that the meeting participants “agree that a chemical’s potency to induce an adverse effect is an important factor for consideration during the characterization of the hazards of endocrine disruptors.” While potency is not relevant for identification of a compound as an endocrine disruptor, there may be high doses (e.g., the oral toxicity limit of 1,000 milligram per kilogram (mg/kg) body weight per day) above which identification as an endocrine disruptor would not be warranted. According to the consensus statement, the criteria for identifying endocrine disruptors would need to be accompanied by the implementation of relevant test systems in EU regulations. The consensus statement recommends that respective EU directives, regulations, and other relevant guidance be updated to incorporate validated and internationally agreed test systems for endocrine disruptors. The consensus statement notes that it has focused on the identification of endocrine disruptors. The assessment of the corresponding risks on human health and wildlife would require further consideration of dose-response relationships, including potency, exposure assessment, and risk characterization, including susceptible sub-populations, severity, and reversibility of effects.JAPANASEAN-Japan Chemical Safety Database Now Available: The Association of South East Asian Nations (ASEAN)-Japan Chemical Safety Database was launched on April 28, 2016. The Database includes regulatory information and GHS classification results, which are provided by the government authorities of each member country, as well as sample safety data sheets (SDS) voluntarily provided by private companies. Users can search the Database by Chemical Abstracts Service Registry Number (CAS RN), chemical name, structural formula, molecular formula, molecular weight, country, and law/regulation. The FAQs note that just because a chemical is not found in the Database does not mean that the chemical is not regulated under any law or regulation. According to the FAQs, a chemical may not be found because the Database is CAS RN-based and contains only chemicals with CAS RNs. In addition, the Database has been developed on a voluntary basis, and “the information update may not be perfect.” The FAQs recommend using the Database as a reference tool. The FAQs state that the detail and the practical information may be inquired from the contact information page to each country.SOUTH KOREAMOE Publishes Model Agreement Guidelines For Joint Submission Of K-REACH Registration Documents: On April 8, 2016, the Ministry of the Environment (MOE) Task Force for the Act for the Registration and Evaluation of Chemicals (K-REACH) announced the availability of a model agreement for the joint submission of registration documents. The model agreement is intended to help lead registrants of the 510 priority existing chemicals (PEC). It includes chapters on:General provisions: Definitions, appointment of lead registrants, and their responsibilities;
Preparation and submission of registration documents for joint submission: Scope, obligations of collaboration, collection, selection and ownership of test data, development of registration documents, submission, rights to share registration documents, and cost sharing;
Agreement Management: Administration of costs;
Confidentiality: Confidential business information (CBI) protection; and
Miscellaneous: Competition law compliance, legal personality, duty of due diligence and indemnification, term and termination, transfer of rights and obligations, and dispute resolution and applicable laws.MOE Announces That South Korea Will Establish Biocides Regulation: In May 2016, MOE announced that it intends to establish a biocides regulation. Currently, biocides are regulated under K-REACH, the Pharmaceutical Affairs Act, the Food Sanitation Act, and the Cosmetics Act. MOE made its announcement after RB, previously Reckitt Benckiser, apologized for health issues and approximately 100 deaths caused by Oxy’s Humidifier Sanitizer (HS). Oxy launched the product in Korea in 1996. The Korean Center for Disease Control suggested a link between the HS product and lung injury in 2011. Oxy, which RB acquired in 2001 and then became Oxy RB, promptly withdrew the product from the market. A MOE spokesperson stated that there is a “big loophole” in how South Korea regulates biocides. Details of the biocides regulation are not yet publicly available, but it will reportedly include elements of the EU’s Biocidal Products Regulation.SWEDENKEMI Drafting Regulation Requiring Reporting For Nanomaterials In Chemical Products: Kemikalieinspektionen (KEMI), the Swedish Chemicals Agency, is drafting a regulation that would require companies that report chemical products to the Swedish products register to provide additional information regarding any nanomaterials contained in the chemical products. KEMI intends the requirement to take effect February 28, 2019. As noted in an item above, the EC has rejected the idea of an EU nanomaterials register, indicating that a public website is preferred. Under the draft regulation, the reporting requirement for nanomaterials would first apply to chemical products manufactured or imported in 2018, and reported in 2019. Companies would be required to report nanomaterial content annually thereafter. On December 1, 2015, KEMI announced that it proposed the reporting requirement to the government. According to the English summary in KEMI’s 2015 report, the proposal covers nanomaterials that have been intentionally added to a product, irrespective of concentration. Product groups that are already exempt from reporting requirements will remain so (i.e., waste, food and animal feed, pharmaceuticals, cosmetics, and tattoo ink). KEMI anticipates that the regulation will be subject to a consultation period from mid-June 2016 to mid-September 2016.UNITED KINGDOM (UK)UK Environmental Committee Launches Microplastics Inquiry: The UK House of Commons’ Environmental Audit Committee has started an inquiry on the environmental impact of microplastics. Microplastics are often released into the sea as they cannot be filtered out fully by wastewater treatment. The Greenpeace UK petition launched in January 2016 urging the UK to ban the use of microbeads in cosmetics obtained more than 264,000 signatures. More recently, Greenpeace UK has suggested that “Over 90% of Britons want Cameron to ban toxic microbeads.”The Environmental Audit Committee requested that written evidence be submitted on several “inquiry terms of reference” by April 15, 2016. One of the questions identified was “[o]ther countries, including the USA, have taken action against microbeads in personal care products. What kind of impact would a similar ban in the UK have on the environmental situation around microplastics?” Key aspects of the inquiry include “the scale, sources and consequences of microplastic pollution in the ocean; strategies for dealing with the problem; and the state of our knowledge on the issue.” The Environmental Audit Committee estimates that there are 250,000 tons of plastic in oceans and states “[r]isks to human and animal health are currently uncertain.”Environmental Audit Committee Chair, Mary Creagh (Member of Parliament), stated “[m]icroplastic beads are used in industrial processes and body care products. Their tiny size means they can end up flushed into the sea and enter the food chain … we will be looking at the health consequences of eating fish containing microplastics and the extent of the damage to our eco-systems. We hope to discuss potential solutions with industry, environmental and consumer groups.”
More information is available in the UK Parliament’s press release, “Environmental impact of microplastics inquiry launched.”