Global Emerging Regulations (GER) Issue Team Quarter 2 Report

Transcription

1 Global Emerging Regulations (GER) Issue Team 2016 Quarter 2 Report July2016

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3 This report covers those non-eu countries where regulatory reform has occurred or continued during quarter Those Cefic Members who only wish to refer to selected regions may click on the list in the table of contents for immediate access. The previous reports issued, were the annual publication for 2015 and the quarter 1 update which are available on request. In case members would like to have information on other countries, Cefic should be contacted for information (Dr. Adriana Jalba, adj@cefic.be) Disclaimer: The information contained in this document is for Cefic s members only and further distribution beyond that is not allowed. Whilst the information is provided in utmost good faith and has been based on the best information currently available, it is to be relied upon at the user s own risk. No representations or warranties are made with regard to its completeness or accuracy and no liability will be accepted by Cefic nor any company participating in Cefic GER for damages of any nature whatsoever resulting from the use of or reliance on the information. 1

4 TABLE OF CONTENTS MAINLAND CHINA (PEOPLE S REPUBLIC) 3 TAIWAN 3 SOUTH KOREA 4 INDONESIA 5 PHILLIPPINES 6 MALAYSIA 7 THAILAND 7 VIETNAM 8 AUSTRALIA 9 NEW ZEALAND 9 EURASIAN CUSTOMS UNION 10 SWITZERLAND 11 US 11 CANADA 12 BRAZIL 12 2

5 MAINLAND CHINA (People s Republic) Headline: Cefic members are alerted to the fact that the China Inventory (IECSC) may reopen for the supplementary submission of substances that were manufactured, imported or used in China before 15 th October Chinese Solid Waste and Chemical Management Center (MEP-SCC) are reported to be willing to accept industry s proposal to consider all possible evidence and proof as it is understand that it is difficult to gather original receipts (invoices, etc) from more than a decade ago. Although MEP-SCC is unable to provide a definite timeline on when the official announcement will be made (due to approval from the minister being needed), Cefic members may wish to start gathering evidence now. For new substances which were notified, manufactured and imported for more than 5 years, MEP-SCC has prepared a procedure on how to add them to IECSC. The procedure will be released in due course. China MEP Order 7 Guidance The publication of the new MEP order number 7 guidance is likely to be released during Q3 this year i.e. after completion of the WTO notification procedure. Annual Reporting of Notified Substances Cefic members are reminded via the link below of a notice issued by MEP-SCC on 22 December 2015 on the annual reporting of notified new chemicals. MEP-SCC has created an IT tool to complete and submit the annual report on-line TAIWAN Phase I Registration According to Article 18 of the Regulation of New and Existing Chemical Substances Registration, all existing chemicals manufactured or imported over 0.1 ton per year (TPA) are subject to Phase I of Taiwan s existing chemical registration (pre-registration). The Phase I registration deadline was 31 Mar A late pre-registration phase has been announced as 1 st of April 2016, but is only applicable to existing chemical substances manufactured or imported over 0.1 TPA for the first time after 31 March The companies that missed the deadline for pre-registration (31 st of March 2016) should selfreport and apply for supplementary pre-registration, according to the guidance issued on 10 May In April the Custom Supervision and Inspection Section System was initiated and an IT platform of Chemical Commodity Importation Pre-Confirmation (CCIP) was launched 3

6 Stakeholders consultations Taiwanese authorities asked the stakeholders for feedback and suggestions on the implementation on revised TSCSA. The consultation closed on the 28 th of June. Cefic took the opportunity to highlight once again the need to clarify the status of the Third Party Representative (TPR), which in the current set-up give raise to many issues such as multiplication of registrations or CBI and data ownership protection concerns. Practical suggestions regarding the use of QSAR and weight-of-evidence were once again made. Currently, a draft Guidance on Hazard Assessment and Exposure Assessment is available for public consultation until mid-august. The draft is available in Chinese only. Cefic is currently seeking an English translation to give input in the process. SOUTH KOREA Revision of the Enforcement Decree Korean Ministry of Environment (MoE) issued for public consultation a revised draft of the Presidential Decree (Enforcement Decree) on 20 April 2016 (Notice No ). Important changes were proposed as below: Operational scope of the Chemical Substance Evaluation Committee is further specified (Article 5 of Presidential Decree). Currently existing chemical substances with sufficient information indicating low hazard, if designated and published by the MoE, can be exempt from annual reporting. In the draft proposal both existing chemical substances and new chemical substances can be exempt as long as they satisfy the above criteria (Paragraph 4, Article 8 of Presidential Decree). For chemical substances in which annual production or import quantity is less than 10 TPA and the hazards posed to human health and the environment can be determined by applying QSAR, part of the testing data can be omitted according to Article 14 of the K-REACH Act. However, the applicable range for QSAR data will expand and there would be no tonnage limit for QSAR utilization in this aspect according to the draft proposal (Paragraph 3, Article 13 of Presidential Decree). Support to SMEs in terms of chemical registration and evaluation will be specified (Paragraph 2, Article 29 of Presidential Decree). Delegation and entrustment of Authority, i.e. issues regarding revocation of approval of the use of results of hazard evaluation were entrusted to NIER; issues regarding support to SMEs were entrusted to KCMA (Paragraph 1 and 3, Article 31 of Presidential Decree). This revision proposal was made to give more support to SMEs and facilitate industry compliance. An important issue for Cefic members to note is that originally read across data and data from literature and other similar sources could only be used for registration of <10 TPA 4

7 substances. Use of non-test data to fill the data gaps in the registration dossier was a longstanding point on Cefic s advocacy agenda in Korea and Cefic has submitted feedback in the public consultation (end of May). Guidance on QSAR data submission was published by MoE Support Group on April 4th, This guidance suggests QMRF (QSAR Model Reporting format) and QPRF (QSAR Prediction Reporting format) as submission format of QSAR data with examples, highlighting the limitations of QSAR data. A simple submission of predictable value only is hardly acceptable. Hence, QMRF and QPRF should be submitted together. Pre-announcements on use restriction Complementary to K-REACH implementation, MoE made 4 pre-announcements on restricting uses for certain substances that fall under the first K-REACH registration deadline. Thus, the existing chemicals substances list is revised and new additions are made to the List of Toxic, Restricted and Prohibited substances. K-REACH implementation status and related regulations In May the Korean Chemical Management Association (KCMA) with MOE hosted an event on K-REACH to date and the future. A presentation by Cefic was made at the event. Issues such as overlap and synergies with EU REACH, data sharing, OR issues and future SVHC policies were discussed. For the registrations of Priority Existing Substances (PEC), MoE will provide financial support to K-SIEFs to cover consultation/management fees required to support the joint submission. By the end of June 2016, a lead registrant was elected for only 221 PECs out of the designated 510. The deadline for the Annual Reporting was 30 June 2016 (for the substances manufactured or imported in the previous year). Guidance for Annual Reporting was issued by MoE March this year. Overseas manufacturers can submit directly the information considered CBI - chemical name/ CAS no., volume, uses (via the IT system): The humidifier disinfectants incidents have provoked controversy nationwide over the safety of household chemical products such as air-freshener products, deodorizing agents, etc. Consequently, regulations on biocides will be more stringent and MoE will implement EU BPR-like regulation. MoE has started a complete survey on biocides in household products. INDONESIA Draft management of Hazardous and Toxic Substances The Draft Management of Hazardous and Toxic Substances (Replacing Regulation Number 74 of 2001), is currently available in local language. Details are as follows: Activities covered in the draft include: production, import, export, transportation, distribution, storage, utilization processing, waste discharging, (Chapter 2). 5

8 In terms of chemicals, this covers substances, mixtures, and products containing the Hazardous and Toxic Substances (HTS). HTS need to be classified for phys-chem, human health and environmental properties. There are 3 chemicals Categories covered in the draft: Chemicals with limited use (45 substances), Chemicals prohibited for use (10 substances), and Chemicals can be used if certain conditions are met (209 substances). The substances list remains the same as in Regulation 74. Companies wishing to produce or import for the first time substances that are not listed in this regulation should submit an application for HTS categorisation. Criteria would be made based on characteristic test. HTS need to be classified for phys-chem, human health and environmental properties. The producer or importer will submit the characteristic result (including SDS) to HTS committee to obtain approval. Newly imported or produced HTS should first a risk analysis. The risk analysis should be done by producer and evaluated by HTS evaluation team. Chemicals with limited use should go through notification process both for import or export. Every party who import, export, distribute, produce HTS should have registration identification. Registration is valid for 5 years. PHILLIPPINES Two issues have emerged since the publication of the Q1 report: The Food and Drug Administration Philippines (PH FDA) removed Licensing and Certification requirements for HUHS (Household and Urban Hazardous Substances). It appears that the Philippines will rely on safety of products following foreign standards. The focus of the PH FDA will be on food, drugs and goods that have a higher impact on the health and well-being of Filipinos. The PH Dangerous Drug Board has issued an exclusion of permit application on most of the imported Finished Good products. The Comprehensive Guidelines on Importation, Distribution, Manufacture, Prescription, Dispensing and Sale of, and Other Lawful Acts in Connection with Any Dangerous Drugs, Controlled Precursors and Essential Chemicals and Other Similar or Analogous Substances" have been amended. It addresses drugs, chemicals in preparations that may be considered precursors to drugs and a wide variety of other products that may contain controlled substances. 6

9 MALAYSIA Draft Regulation on Environmentally Hazardous Substances The Department of Environment held a consultation with the industry on the first public draft of the Environmentally Hazardous Substance (EHS) Regulation in December Industry has been expecting DOE to formalise the voluntary EHS Notification and Registration scheme. However, this draft EHS Regulation has 2 major objectives: 1. provide a legal mechanism to implement international conventions/multilateral agreements (e.g. Rotterdam, Stockholm) in Malaysia 2. regulate EHS in Malaysia where there are gaps in existing regulations (impact is largely on industrial chemicals) The draft regulation attempts to regulate hazardous chemicals in a more comprehensive manner, starting with identifying environmentally hazardous substances in commerce, tracing the supply chain, evaluating them through a risk assessment process and imposing risk management actions as necessary in the form of permitting, restrictions, or prohibitions. It is considered that the two main objectives should be addressed in separate regulations instead of combining them into one regulation as they are each quite significant, especially the objectives around environmentally hazardous substances. Unfortunately at this time industry is not able to share the draft regulation outside of Chemical Industries Council of Malaysia (CICM), but it has provided feedback to DOE with several key messages, including: having separate regulations for multilateral conventions and for management of Environmentally Hazardous Substances regulating these in a step-wise manner, starting first with a regulation to make voluntary the notification of these substances and at a later stage a mandatory registration scheme. The feedback seems well received and it is likely that there will be further opportunities to interact on this development. THAILAND Revision of the chemicals management system As previously reported, The Department of Industrial Works (DIW) has announced that they are planning to revise their chemicals management system, which will include the creation of a national inventory of existing chemical substances. It has also been mentioned that to ensure an inventory listing it may be necessary to file a List 5.6 notification to DIW and that the expected cut-off date for notification to ensure a substance is defined as existing remains December 31, Whilst it has been suggested that the intention is not to establish a conventional new chemical notification scheme but to understand those chemicals are in Thailand and after an evaluation, in the form of a risk assessment, DIW will determine which chemicals that need to be additionally added to the list of controlled chemicals that currently exists. 7

10 The decision to notify or not is important as on one hand there could be commercial and financial implications for not obtaining existing substance status for their chemicals, whilst on the other hand there is a risk that non-hazardous chemicals could be perceived as hazardous. As for CBI, DIW has a notification procedure envisaged i.e. the 3 rd party reporting process, but there will be the need for industry to further explain various other aspects of CBI, for example where the very existence of the chemical is confidential. DIW representatives expressed a willingness to learn more about industry s concerns. GER is seeking clarity and following developments. VIETNAM WTO notification of the Vietnam Labelling Law For information, the following summary from the WTO notice on the Vietnam Labelling Law is provided. The full text is only available in Vietnamese. 7. Title: Draft Decree amending and supplementing a number of articles of Decree No.80/2006/NÐ-CP of 30 August 2006 of the Government on labelling of goods 8. Description of content: This draft Decree amends and supplements a number of articles of Decree No.80/2006/NÐ-CP of 30 August 2006 of the Government on labelling of goods as follows: Article 1. Scope of regulation Article 3. Definition of terms Article 5. Mandatory labelling Article 6. Labels position Article 7. Labels dimension Article 10. Responsibility for goods labelling Article 11. Contents required to be shown on goods labels Article 12a. (Supplemented) Goods classification for labelling Article 13. Goods name Article 14. Name and address of institutions and individuals responsible for goods Article 16. Manufacturing date, expire date, preservation date Article 17. Goods origin Article 19. Specifications, information, warning, sanitary, safety Article 20a. (Supplemented) Supplementary labelling Article 20b. (Supplemented) Distinguishing commercial packaging and non-commercial packaging containing goods Article 24 (removed) Article 25. Handling violations of goods labelling The following goods are exempted from scope of application of the draft Decree: a) Real estate b) Temporarily imported goods for re-exporting; temporarily imported goods for fair and exhibition and subsequently re-exported; transited goods; transshipped goods 8

11 c) Gifts; baggage of migrants or immigrants; movable assets 9. Objective and rationale: Quality management of product and goods; labelling requirements 10. Relevant documents: The Law on product and goods quality dated 21 November 2007, The Commercial Law dated 14 June 2005 and The Consumer Protection law dated 30 November Proposed date of adoption: 12/1/ Proposed date of entry into force: Not given by country 13. Final date for comments: 6/30/ Full text regulation URL 1: VNM/83 (PDF) (VIETNAMESE) AUSTRALIA NICNAS reform public consultation In the NICNAS reform Consultation Paper 3, a risk based matrix for chemicals control is proposed. However, the endocrine disruptors and nanomaterials are proposed to be allocated to the highest hazard band. Cefic has submitted general comments in the consultation process, suggesting a case by case approach of endocrine disruptors and nanomaterials. Consultation Paper 4 is proposed is to be released in July Inventory multi-tiered assessment and prioritisation (IMAP) programme IMAP Tranche 17 closed for comments on the 22 nd June. IMAP Tranche 18 reports will be published in the week beginning 27 June Interested parties will be able to comment on these assessment outcomes. Consultation will close eight weeks after publication. NEW ZEALAND Hazardous Substance Reforms The Environmental Protection Authority (EPA) is responsible for approving hazardous substances and setting the rules for classification, labelling, safety data sheets and packaging. They will be setting these rules in EPA notices, which is a new approach for the EPA to set rules under HSNO. 9

12 The new Health and Safety at Work (Hazardous Substances) Regulations and EPA Notices will be gazetted by the end of this year with a view to commencing in the middle of 2017 (date to be confirmed). Details on submissions on EPA notices were covered. Details can be found on the 80 submissions received, and the resulting in the refining on the EPA website: Submissions received Notice proposals for Classification, Labelling, Packaging and Safety Data Sheets. Progressing the EPA notices was also explained in that decisions have been made on how to progress the EPA notices that will be in force when the HSW (Hazardous Substances) regulations take effect. The EPA focus over the next year is delivering the split in functions between WorkSafe and the EPA. The HSW (Hazardous Substances) regulations and EPA notices will be completed by the end of the year. The expected date for these coming into force is the middle of This will give time to prepare guidance and information to help the understanding the new rules will bring about when they take effect. For the Classification system for hazardous substances in New Zealand, a decision around updating the current HSNO classification system to a more recent version GHS has been deferred. Questions can be ed to: hsreform@epa.govt.nz EURASIAN CUSTOMS UNION Development of the Technical Regulation There have been significant developments with regards to the administration of the Eurasian Customs Union (CU) Technical Regulation. This involves the 5 CU states, not just Russia, although Russia is now leading the initiative. As extensively reported during 2015 industry has been leveraging the Kazakhstan Chamber of Entrepreneurs to work with the Kazakhstan authorities to advocate for a pragmatic approach to be taken and adopt reasonable measures. To date industry has been able so far to delay progress of Technical Regulation. However due to political perceptions and changes especially recent changes in the Kazakhstan government industry s ability to influence has been significantly reduced. Consequently by end 2017, the Customs Union will establish an inventory of existing substances and mixtures. This will be based on the current inventory of notification/registration of substances and mixtures in the 5 CU countries. Following this, all new substances and mixtures per legal entity which are not on their inventory will need to be notified and registered regardless of their volume and classification. Notification of new substance will require phys-chem, toxicological and ecotoxicological tests plus carcinogenicity, mutagenicity and bioaccumulation tests. In its current form, the Draft Customs Union Technical Chemical Regulation appears far more onerous than REACH The expected timing is as follows: CU Technical Regulation expected to be published before the end of 2016 Completion of the inventory of existing substances and mixtures by the end 2017 Implementation of the legislation by

13 The need for urgent advocacy work has been identified. Global and OECD support will be sought. SWITZERLAND Revision of the Chemicals Ordinance Industry associations are working behind the scenes with the authorities on the preparation of the coming revision of the Chemicals Ordinance. The official public process is due to start later this year in order to have the revised ordinance in force by early The main points are as follows: Introduction of a registration requirement ( Anmeldepflicht ) for phase-in substances which remain on the Swiss market but are not registered under REACH by 2018 Introduction of a registration requirement ( Anmeldepflicht ) for nanomaterials Introduction of a reduced registration requirement ( Meldepflicht ) for marketed intermediates Anmeldepflicht is similar to a REACH registration requirement and Meldepflicht is letting the authorities know the substance identity its, classification and labelling, intended uses, if it is considered dangerous, and the tonnage band (<1 / 1-10 / />100 t/a). Intermediates for the companies own use, do not need to be notified at all, here the status quo remains. The Anmeldepflicht for nanomaterials is considered problematic because it would affect not only new substances but phase-in (old and very old substances) as well. In addition the definition of what is to be considered as a nanomaterial is not completely free of controversy. Advocacy work continues. The Anmeldepflicht for substances which are not registered under REACH by 2018 is so far not considered to be a great issue, as companies expect chemicals either to be registered under REACH or disappear from the Swiss market. Additionally there is one element which the authorities informed industry about: Introduction of a notification requirement ( Meldepflicht ) for the handling of nanomaterials. This mainly targets downstream users (formulators) but, according to the authorities, it is not intended to target the use of market ready end-use formulations used by e.g. painters, car manufacturers and so on. The actual wording is unclear. Industry is working with the authorities on several points where clearer definitions are needed. US Revised TSCA The US House of Representatives has passed a final negotiated bill to reform the Toxic Substances Control Act (TSCA). The bill passed by a margin and was signed into law by The White House on 22 nd June

14 The new law will bring many changes for industry, including the ability to request EPA to conduct risk assessments. The EPA is expected soon to post its plans for implementing the TSCA reform. CANADA Chemicals Management Plan Third Phase Environment and Climate Change Canada and Health Canada have launched the third phase of their Chemicals Management Plan (CMP). This will address the remaining 1,550 substances of the 4,300 identified on Canada s Domestic Substance List (DSL) as requiring health and ecological assessment. Since the beginning of the CMP, close to 400 substances have been found harmful and nearly 80 risk management actions have been put in place to address risks from these l substances. The list of substances in the next phase of the CMP and Two-year Rolling Risk Assessment Publication Plan is now available. Further public information can be found on the websites of the Canadian authorities, e.g. * General information on CMP3: * Substances affected by CMP3: BRAZIL Public consultation on Draft Regulation of Industrial Chemical Substances On June 30 th, a draft legislation (Regulação de Substâncias Químicas Industriais) was released for a 45 day commenting period. The regulation consists of 17 Articles that follows a stepwise type approach. The intention is to create a national inventory of the chemical substances on the Brazilian market, and then to prioritize the substances to be assessed (PBT, CMRs, endocrine disruptors, substances that may be relevant due to the exposure and substances subject to international conventions). Article 15 directs the Executive Branch to promulgate the law within 180 days of the date of its publication. It appears that full compliance will be required as of December 27, A critical review will be undertaken and full details will be reported in the next quarterly report. 12