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November 1, 2014

Global Regulatory Update for November 2014

The ACTA Group


Government Will Examine Opportunities For Greater Acceptance Of International Standards And Risk Assessments: In an October 14, 2014, joint media release, Prime Minister Tony Abbott and Parliamentary Secretary to the Prime Minister announced that, as part of the Industry Innovation and Competitiveness Agenda, the government will examine opportunities for greater acceptance of international standards and risk assessments. The joint media release notes that businesses often have to undertake a regulatory approvals process to use or sell products in Australia that duplicates a process that has already occurred in other developed countries. This adds to costs and provides little or no additional protection. According to the joint media release, the government “will adopt a new principle that if a system, service or product has been approved under a trusted international standard or risk assessment, then our regulators should not impose any additional requirements for approval in Australia, unless it can be demonstrated that there is a good reason to do so.” The government “will also require the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) to increase its acceptance of international risk assessments of industrial chemicals made by reputable international regulatory authorities such as the European Union regulator.” More information is available in the joint statement, “Further measures to cut red tape — accepting trusted international standards.”

NICNAS Posts FAQs On New Chemicals: NICNAS has added new frequently asked questions (FAQ) to its website for notifiers of new chemicals. According to NICNAS, the FAQs include questions on which NICNAS has provided previous advice, such as whether certain groups of chemicals are considered reactive functional groups for the purposes of the polymer of low concern criteria, as well as more general questions regarding the data requirements for notifications, such as the requirements for providing chemical names. The FAQs concerning new chemicals are available online.


Austria Begins Nanomaterial Inspection Project: According to a guest column in the October 2014 European Chemicals Agency (ECHA) newsletter, Austria has begun a nanomaterial inspection project. One of its goals is to find out if the current Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) requirements are being fulfilled. It also aims to clarify how inspectors can be helped to identify nanomaterials on the market and what kind of training they need. Spot checks are conducted to gain insight into nanomaterials and nanomaterial products on the Austrian market. Austria will share the results of its project with the national enforcement authorities in other Member States. The inspection activities will be concluded by the end of 2014, and the final project report is expected in March 2015. The guest column is available online.


MEP Releases Draft Interim Measures Related To The Environmental Protection Law For Public Comment: On October 17, 2014, the Ministry of Environmental Protection (MEP) released for public comment four interim measures related to amendments to the Environmental Protection Law that will take effect on January 1, 2015. The amended Environmental Protection Law sets environmental protection as China’s basic policy. Under the amended Law, economic and social development should be coordinated with environmental protection. It encourages studies on the impact environmental quality has on public health, urging prevention and control of pollution-related diseases. The amended Law also increases punishments for environmental wrongdoing. The draft interim measures include:

  • Interim Measures of Consecutive Daily Fines for Violating Environmental Protection Regulations (draft): The Measures define the criteria for the consecutive daily fines and their duration, number, amount, implementation procedures, and the related terminology;
  • Interim Measures of Seizure and Detention for Violating Environmental Protection Regulations (draft): The Measures define the criteria for seizure and detention for severe environmental pollution and contamination and their duration, implementation procedures, and the related terminology;
  • Interim Measures for Restrictions and Suspension of Production for Violating Environmental Protection Regulations (draft): The Measures provide implementation procedures on investigation, approval, implementation of corrective actions, reinstatement, and inspection related to the restrictions and suspension of production for severe environmental pollution and contamination; and
  • Interim Measures for Disclosure of Compliance Information of Environmental Protection Regulations of Enterprises and Institutions (draft): The Measures give prescriptive guidance on disclosure scope, content, manner, and supervision of the compliance information of environmental protection regulations of enterprises and institutions.

Comments on the four draft interim measures were due October 26, 2014. The four interim measures are expected to be issued in final by the end of 2014. More information is available, in Chinese, in MEP’s October 17, 2014, notice.


ECHA Publishes First Official Article 95 List: The European Chemicals Agency (ECHA) announced on September 24, 2014, that following a correction exercise of the provisional list of active substances and suppliers, the first official Article 95 list under the Biocidal Products Regulation (BPR) is now available on its website. ECHA states that the list includes the names of substance suppliers, their countries, and product suppliers for relevant biocidal active substances, together with information about which product-types (PT) they are included for. Participants in the review program, supporters of new active substances, and submitters of product authorization applications where the application includes an alternative active substance dossier (“third party” dossier) are also listed. Beginning September 1, 2015, a biocidal product cannot be made available on the EU market unless either the substance supplier or the product supplier is included in the Article 95 list for the PT to which the product belongs. More information is available in ECHA’s press release, “Official Article 95 list for biocides published.”

ECHA Publishes Practical Guide On The BPR: ECHA has published a Practical Guide on the BPR. ECHA intends for the Practical Guide to help companies fulfill their obligations and tasks under the BPR. The Practical Guide is structured in sections describing the principles behind each obligation; who is concerned by the obligations; the relevant timelines and deadlines; the information requirements; the procedure to follow; and the expected results of the process. The guide also highlights the exceptions and particular cases for some of the processes. Finally, it lists the relevant fees for each obligation. More information is available in ECHA’s press release, “ECHA publishes a Practical Guide on the Biocidal Products Regulation.”

EC Begins Public Consultation On Defining Criteria For Identifying Endocrine Disruptors: On September 26, 2014, the European Commission (EC) began a public consultation on defining criteria for identifying endocrine disruptors in the context of the implementation of the Plant Protection Product Regulation (PPPR) and the BPR. The EC states that the PPPR and BPR require the EC to “specify scientific criteria for the determination of endocrine-disrupting properties” of chemical substances. Pending adoption of these criteria, interim criteria for identifying endocrine disrupting chemicals apply. The EC is carrying out an impact assessment according to its standard procedures. More information about the context of the initiative is published in the roadmap, Defining criteria for identifying Endocrine Disruptors in the context of the implementation of the Plant Protection Product Regulation and Biocidal Products Regulation. The EC recommends that stakeholders read the roadmap, which provides background to this dossier, sets out the scope of the impact assessment, and presents the policy options that are being assessed in the impact assessment, before responding to the consultation. Comments are due January 16, 2015.

Seven Substance Evaluation Cases Concluded Without Draft Decisions: ECHA announced in its October 1, 2014, e-News that seven out of 47 substance evaluation cases from 2013 are now published. In all of these cases, the evaluating Member State decided not to ask for any further information on the substances, and hence no draft decision was prepared. The conclusion documents and the evaluation reports are published on ECHA’s website. The conclusion document provides the view of the evaluating Member State on the need for regulatory risk management measures. The seven substances are butanone oxime (EC Number 202-496-6, evaluated by Germany); benzothiazole-2-thiol (EC Number 205-736-8, Germany); beryllium (EC Number 231-150-7, Germany); maleic anhydride (EC Number 203-571-6, Austria); 1,3,5-trioxane (EC Number 203-812-5, Poland); 1,1′-iminodipropan-2-ol (EC Number 203-820-9, Czech Republic); and tetrachloroethylene (EC Number 204-825-9, Latvia).

ChemSec Updates SIN List And Launches SINimilarity: On October 8, 2014, the International Chemical Secretariat (ChemSec) announced that it updated the Substitute It Now! (SIN) List with an additional 28 chemicals for priority action and launched SINimilarity, “a tool for identifying SIN-like chemicals and thereby avoiding non-sustainable substitution.” According to ChemSec, many of the 28 chemicals added to the SIN List “are chemicals that have been used to replace better known hazardous substances, but are in fact just as problematic,” such as Bisphenol F, Bisphenol S, and modified versions of regulated brominated flame retardants and fluorinated chemicals. ChemSec has divided the SIN List into 31 groups based on structure and toxic properties, including bisphenols, phthalates, and perfluorinated compounds. ChemSec notes that this grouping also served as the base for SINimilarity. ChemSec states that SINimilarity “makes it possible to search among 80,000 chemicals and find out if they are similar to any of the chemicals on the SIN List.” More information is available in ChemSec’s October 8, 2014, press release, “SIN List updated and new tool, SINimilarity, launched.”

EC Promulgates Regulation For Review Of Existing Biocides: The October 10, 2014, Official Journal of the European Union includes the regulation concerning the work program for the systematic examination of all existing active substances referred to in BPR Article 89. The regulation lists all substances and their product-types that are currently supported for review, as well as those that will be withdrawn. Companies have until October 30, 2015, to notify ECHA or the EC if they want to support products that are not covered under the active substances and uses to be reviewed.

ECHA published a notice on October 30, 2014, when the regulation entered into force. According to ECHA, key aspects of the regulation include:

  • Listing the active substance/product-type combinations currently in the review program;
  • Listing the active substance/product-type combinations not currently supported by at least one participant;
  • Defining Member States’ deadlines for submitting their assessments of the active substances to complete the review program by 2024 (as set in the amended BPR);
  • Detailing the procedure for joining and replacing participants supporting active substance/product-type combinations;
  • Defining the specific cases where active substance/product-type combinations can be added to the review program. A specific case, ECHA states, is when the substance benefitted from a derogation for food and feed under the previous review program regulation. Deadlines apply for declaring an interest to notify an addition of an active substance/product-type combination; and
  • Clarifying that nano forms of active substances require notification within 12 months to remain in the review program. This requirement applies to all active substances except silver absorbed on silicon dioxide (as a nanomaterial in the form of a stable aggregate with primary particles in the nanoscale) and silicon dioxide (as a nanomaterial formed by aggregates and agglomerates), as these two substances are already included as nanomaterials in the review program.

Biocidal products that contain active substances that are included in the review program can be made available and used subject to national laws until three years after the date of approval of the last active substance/product-type combination in the product. The active substance/product-type combinations included in the review program but not currently supported by a participating company are listed in part 2 of Annex II of the new regulation. Companies interested in supporting those active substances are invited to prepare their notifications, which are due October 30, 2015. More information is available in ECHA’s notice, “New Biocides Review Programme Regulation enters into force.”

ECHA Unveils Web Pages For 2018 Registration Deadline: ECHA announced on October 13, 2014, that it has launched a set of new web pages related to REACH 2018, which outline the phases leading to a successful registration. According to ECHA, the pages will help companies to begin their preparations now and give them easy access to current information on ECHA’s website. ECHA states:

The registration process has been divided into seven phases and each phase has its own web page. Each of these pages provides key information, practical tips for registrants and links to further information relevant for that phase. Special attention has been paid to ensure that the content is understandable also to small and medium-sized enterprises. The links lead to three levels of reading: getting started, essential reading and going deeper. The new REACH 2018 web pages are available in 23 EU languages.

More information is available in ECHA’s notice, “REACH 2018 web pages unveiled.”

EFSA Guidance Provides Harmonized Methodology For Calculating Exposure To Pesticides: The European Food Safety Authority (EFSA) announced on October 23, 2014, new guidance that, for the first time, sets out a harmonized methodology for four major population groups — operators, workers, residents, and bystanders. EFSA intends the guidance to help risk assessors and industry applicants evaluate the risk to people who come into contact with pesticides as part of their job or through physical proximity to areas such as fields where pesticides are used. The guidance evaluates non-dietary exposure to these chemicals, mainly by inhalation and absorption through the skin, but also due to potential ingestion via hand-to-mouth transfer. As part of the guidance, EFSA developed a “user-friendly software tool that carries out these exposure assessments with a single mouse click.” According to EFSA, by inputting key data, the calculator indicates whether the level of pesticide exposure for a particular group under specific circumstances is above or below previously set guidance values for acceptable exposure. EFSA states that the tool “incorporates a high safety factor by considering both realistic and worst case scenarios for exposure assessments.” EFSA notes that all evaluations assume that operators and workers follow recognized safety procedures when dealing with pesticides. EFSA highlights that the guidance contains a number of uncertainties due to a lack of data, particularly for the assessment of resident exposure. EFSA “is calling on scientists from Member States, research bodies and industry to fill these data gaps as part of an on-going review of the guidance.” The guidance on the assessment of exposure of operators, workers, residents, and bystanders in risk assessment for plant protection products is available online.

ECHA Clarifies Interface Between REACH And The Cosmetics Regulation: ECHA published a notice on October 27, 2014, entitled “Clarity on interface between REACH and the Cosmetics Regulation.” ECHA states that substances used in cosmetic products may need to be registered under REACH but, under certain circumstances, registrants may not have to conduct animal testing. To meet the requirements of the new Cosmetics Regulation (Regulation (EC) No 1223/2009), cosmetic products are prohibited from being placed on the market where the final formulation, ingredients in a final formulation, or a finished product have been subject to animal testing. Those same chemical ingredients may, however, also need to be registered under REACH. The EC, in cooperation with ECHA, has clarified the relationship between the marketing ban and the REACH information requirements as follows:

  • Registrants of substances that are exclusively used in cosmetics may not conduct animal testing to meet the information requirements of the REACH human health endpoints, with the exception of tests that are done to assess the risks to workers exposed to the substance. In this context, workers refers to those involved in the production or handling of chemicals on an industrial site, not professional users using cosmetic products as part of their business (e.g., hairdressers);
  • Registrants of substances that are used for a number of purposes, and not solely in cosmetics, are permitted to conduct animal testing, as a last resort, for all human health endpoints; and
  • Registrants are permitted to conduct animal testing, as a last resort, for all environmental endpoints.

ECHA notes that registrants of substances registered exclusively for cosmetic use will still have to provide the required information under REACH by using alternatives to animal testing wherever possible.

ECHA Will Change Administrative Charge: After the General Court annulled ECHA’s decision to impose an administrative charge on a company, ECHA announced that it will change the administrative charge. In the case, ECHA levied the charge following its check of the company’s size; ECHA found the company to be large and not small as it had self-declared. The company also received an invoice for the difference in fee payable because of its size. ECHA states that it looked carefully at the court’s judgment and considered what changes it should make to bring the charging practice into line with the court’s decision. According to the notice, ECHA understands that the General Court confirms the principle that ECHA undertakes small- and medium-sized enterprise (SME) verification to ensure that only genuine SMEs profit from the fee reduction. ECHA notes that the administrative charge should not only be based on the workload, however, but needs to be proportionate compared to the amount of fees that the large company avoided by registering as an SME. ECHA’s Management Board will discuss the new charges at their meeting in December 2014. ECHA is currently assessing the extent to which the judgment has implications for other cases pending before the court. ECHA recommends that companies double-check whether they correctly applied the EC SME Recommendation when they registered. If they did, or if they correct the mistake on their own initiative, they will not have to pay any administrative charge. More information is available in ECHA’s notice, “General Court has annulled ECHA’s decision regarding administrative charge.”

ECHA Launches SPC Editor For Biocides Authorization: ECHA announced on October 28, 2014, that it has launched the Summary Product Characteristic (SPC) Editor, a new online tool to be used by companies and authorities for the authorization of products and product families under the BPR. According to ECHA, the new tool helps companies to apply for authorization for their products either on a national or European level by creating structured summaries of the characteristics for both products and product families. ECHA states that the tool is fully compatible with the new version 3.2 of R4BP, which will be launched on December 3, 2014. The SPC provides R4BP with some of the data that are necessary for product authorization. The new SPC format will be mandatory for new product authorization from December 2014 onwards. It will not be mandatory for the renewal of a product authorization. ECHA’s notice, “New Summary Product Characteristic (SPC) editor for biocides authorisation,” is available online.

ECHA Publishes Draft CoRAP Update For 2015-2017: ECHA published on October 30, 2014, a draft proposal to update the Community Rolling Action Plan (CoRAP) for 2015-2017. The draft update includes 65 newly selected substances and 69 substances from the March 2014 CoRAP. The ECHA Member State Committee will prepare an opinion on the draft CoRAP in February 2015. ECHA will then adopt the final CoRAP update on the basis of the Committee’s opinion. ECHA notes that the CoRAP process does not include a public consultation, but states that, by publishing the draft list of substances, “ECHA informs stakeholders of the progress made and encourages registrants of the substances to start coordinating their actions and to have early interactions with the evaluating Member States.” ECHA states that it intends to adopt and publish the final CoRAP update by the end of March 2015. The final CoRAP update 2015-2017 will indicate the Member State responsible for the evaluation of each substance and the initial reasons of concern together with justification documents. Once ECHA publishes the final CoRAP update, the respective Member States have one year to evaluate substances specified for 2015 and, where regarded as necessary, to prepare a draft decision for requesting further information to clarify the suspected risks. More information is available in ECHA’s notice, “Draft CoRAP update with new substances for evaluation in 2015-2017 published.”

Enforcement Forum Publishes Multi-Annual Work Program For 2014-2018: The Multi-Annual Work Programme of the Forum 2014-2018, which the Enforcement Forum published in October 2014, sets the longer term priorities and key tasks of the Forum for the upcoming years. The Enforcement Forum considered the key points of ECHA’s Work Program, the upcoming deadlines, the most challenging provisions, and built on the experiences of the past years. While the national enforcement authorities have their own priorities and work plans, the Enforcement Forum’s Multi-Annual Work Program “gives a good hint on what may be addressed in the upcoming years during enforcement of the REACH, CLP and PIC regulations.”

EC Begins Stakeholder Consultation On RoHS Exemptions: On October 31, 2014, the EC began a “Stakeholder consultation on exemptions from the substance restrictions in electrical and electronic equipment (RoHS Directive).” The exemption requests are:

  • Exemption request 2014-1: Cadmium Anodes in Hersch cells for high-sensitivity oxygen sensors; and
  • Exemption request 2014-2: Lead in solders used to make electrical connections to temperature measurement sensors designed to be used periodically at temperature below -150C.

Comments are due January 9, 2015.


MOE Releases Draft List Of Existing Chemicals Selected For Registration Under K-REACH: The Ministry of Environment (MOE) published a draft list of the first batch of existing chemicals selected for registration under the Act for the Registration and Evaluation of Chemicals (K-REACH). The 518 chemicals on the list, which has also been made available by the Korean Chemicals Management Association (KCMA), were selected based on a number of criteria, including their designation as carcinogenic, mutagenic, or reprotoxic, and toxic to the aquatic environment in the EU. The final list is expected to be published in June 2015. Once the list is officially published, listed substances must be registered within three years. The next batches of existing chemicals selected for registration are expected to be announced in 2018 and 2021. More information is available, in Korean, in MOE’s announcement and in KCMA’s announcement.