Global Emerging Regulations (GER) Issue Team Quarter 2 Report

Transcription

1 Global Emerging Regulations (GER) Issue Team 2017 Quarter 2 Report July 2017

2

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 report issued, was the annual publication for 2016, which is attached for reference in the link: In case members would like to have information on other countries, Cefic should be contacted for information (Maria Ruiz-Cuevas [MCU@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 SOUTH KOREA 3 TAIWAN 4 INDONESIA 4 INDIA 5 AUSTRALIA 5 VIETNAM 7 LAOS 7 EURASIAN ECONOMIC UNION (EAEU) 7 SWITZERLAND 8 TURKEY 8 UKRAINE 9 US 9 BRAZIL 9 COLOMBIA 10 2

5 MAINLAND CHINA (People s Republic) New Guidance Document for MEP Order 7 It is expected that the updated technical guidance will be published, but with further delay in As previously reported the changes expected are as follows: Only relevant exposure route (primarily the oral route) is now required for acute toxicity at level day repeat dose study is required only starting at level day repeat dose study is required only starting at level 3. Full toxicokinetics is not required at either level 2 or 3. Administration charges will be imposed at all levels, full details not currently known. A 10kg/annum de minimis level has been introduced for R&D registrations. Accumulation of tonnages to identify the next level for registration is no longer mandatory for joint registration or repeated registration if the notified substance is not used at the same site. It has been noted that some of the changes / improvements are already being put into practice. The outcome of Order 7 compliance checks by local Authorities in the Shanghai area has not been made publically available, or to MEP-SCC. The Cefic membership is alerted to the fact that a comprehensive revision of Order 7 is planned, which includes comparison with other international regulatory schemes (e.g. REACH, revised TSCA, South Korea, Canada, etc.), with the aim of more effectively managing new chemicals in China. It is anticipated that a new legal instrument will be used with increased status (e.g. regulation by State Council or law by National People s Committee). SOUTH KOREA It is understood that the authorities are attempting to ensure there is alignment of K-REACH with the new TSCA and EU REACH. Data access and mutual recognition are being considered. It should be noted that English language reports are acceptable but summaries have to be in the local language. For biocides, it is recognized that there is duplication in K- REACH and the biocide regulation. An article on fast track control for substances of concern is available on request. The Korea Ministry of Environment has announced the Draft Amendments of Presidential Decree (Enforcement Decree) and Ministerial Decree (Enforcement Rule) of K-REACH for a public consultation with a deadline for comment by July 24, Cefic will provide comments on these draft decrees in line with the stated deadline. A summary of the changes are available on request. 3

6 TAIWAN Revisions to the Toxic Chemical and Substances Control Act (TCSCA) were issued for consultation by Taiwan's Environmental Protection Administration (EPA) on 17 April. Some of the proposals include: - Establishment of a national chemical regulation advisory reporting system which would coordinate the roles of various central and local government agencies. - Removal of the Class four of toxic chemical substances, which pose a health or environmental risk. - Introduction of a category of chemical substances for investigation for those which may unintentionally generate hazardous chemicals but which are not themselves toxic. There would be two subcategories: one for substances, which may affect the environment and a second for those, which may affect health. - Reinforce the emergency response capabilities and powers of central and local government agencies to respond to toxic chemical incidents. The commenting period will be closed on 16 June 2017 and public hearings will follow. It is also understood that the EPA is to release three batches of priority existing chemical substances (PECs) subject to standard registration under Taiwan TCSCA. The first batch of 122 PECs has been drafted. INDONESIA The Indonesian authority is currently revising Regulation number 74 (Year 2001) concerning the Management of Hazardous and Toxic Substances. In the new regulation, the number of regulated substances (B3 chemicals) will be expanded and will include mixture products, which are not covered in the list. 1. Products that are not listed in Regulation 74 list need to be categorized or classified as: can be used, prohibited, or require notification. 2. The categorization would be organized by a B3 (Hazardous and Toxic substances) Commission, which needs to be formed through President decree. As the B3 Commission has not been established yet, the registration for mixture products that are not listed in Regulation 74/2001 Year is not required until this happens. 3. Registration numbers for mixture products are no longer applied and such products can be imported without registration (including products for which the registration number has expired). Mixtures which contain forbidden substances will remain prohibited and not allowed to be imported or used in Indonesia. 4

7 INDIA The Indian Ministry of Environment, Forests and Climate Change has formed a National Coordination Committee of experts and officials to create a national action plan to address chemical regulation, management and pollution in India. So far no deadline has been set up to, actually bring National Chemical Policy or regulations in place. Probably the members of this committee will visit chemical companies to seek their opinion about its current need, existing regulations, etc. Developments will be monitored. AUSTRALIA The Australian Government is reforming the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and the fifth NICNAS consultation has been released. The deadline for comment is 12 th July Cefic will provide comments on the consultation in line with the stated deadline. Detailed information is available on request, a summary of the consultation paper features below: Aim: To provide stakeholder opportunity to feedback on matters to be included in the delegated legislation. (Other elements of the reforms, which will not be part of the delegated legislation are to be consulted on later this year which includes evaluations initiated by AICIS and how the new CBI protection will work). Overview of content: Details for unlisted chemicals when determined as being exempt, reported or assessed. Details are provided on the hazard and exposure criteria for categorisation. Human health and environmental risks must be considered. Human Health Exposure bands Key changes since consultation paper 3 Change to terminology end uses that will and will not result in intentional human exposure to recognise it is not only cosmetics which are associated with intentional exposure to the public Low volume threshold (<10kg/annum) added R & D criteria have been refined Human Health Hazard bands Key changes since consultation paper 3 Nanomaterials removed and how to deal with these materials is covered in part 7 of consultation paper 5 Addition of some non-ghs hazard statements applicable in Australia Physical hazards omitted from band B Categorisation outcomes for polymers and chemicals with sequences of fully fluorinated carbon atoms have been refined. Environment Exposure bands Key changes since consultation paper 3 Change in terminology to refer to treated release volume Addition of a low volume threshold band 5

8 The irreversible bound within an inert matrix criterion in exposure band 5 was removed Environment Hazard bands Key changes since consultation paper 3 Nanomaterials removed and how to deal with these materials is covered in part 7 of consultation paper 5 Synthetic greenhouse gas chemical added to hazard band E Hazard band B refined criteria for polymers and inorganic chemicals Refined and clarified the categorisation outcomes for polymer and chemicals containing sequences of full fluorinated carbon atoms Explicit details are given on the international assessments accepted for introduction of potentially higher risk chemicals as reported, which would otherwise be categorised as assessed. Details on the hazard information requirements are given in part 5. This includes details of options on how to demonstrate a chemical is not hazardous for human health per exposure band and those required to categorise a chemical for the environment as assessed or not (or exempted). The supporting material ( data/assets/pdf_file/0011/50060/cp5_supporting-material- FINAL pdf) gives further details on the specifics of information requirements to categorise chemicals for introductions. Part 6 provides details on additional requirements for specified chemical introductions where it is deemed that the minimum information requirements will not be enough to determine the indicative risk. Nanomaterials as mentioned above are discussed in part 7 as to how unlisted chemical will be introduced at the nanoscale. Nano-scale chemicals will have their own hazard and exposure band criteria for categorisation, they have moved away from the option that all nanomaterials being looked at as assessed however the thresholds are low for not being assessed; Exempted if introduced at 10 kg/annum for the purposes of research and development, or as a contained import/export introduction Reported if introduced at >10 kg/annum and 100 kg/annum for the purposes of research and development Assessed in all other circumstances. The categorisation criteria are discussed in the paper and looks at the following elements as opposed to having a static definition of nanomaterial; size and distribution intentionally manufactured size-dependent properties aggregates and agglomerates solubility/dissolution rate Commercial evaluation authorisation Ban on the use of new animal test data for cosmetic ingredients Amendment to the 2% rule for polymers, additional criteria to use the rule; any such additional monomers and reactants that constitute no greater than 2% weight of the unlisted polymer must not be known or suspected of being: - persistent, bioaccumulative and toxic (PBT) according to the national PBT criteria; or - chemicals containing a sequence of one or more fully fluorinated carbon atoms; or - chemicals that contain mercury, lead, cadmium or arsenic 6

9 Key changes to the PLC criteria are detailed including; criterion relating to fluorinated polymers, stability criterion, reactive function groups and polyesters. VIETNAM The Cefic membership is again alerted to the fact that Vietnam is creating a national chemicals inventory plus new substance notification scheme. The draft inventory which was released in September 2016 is available at the following link: tory.html LAOS The Cefic membership is reminded that the Laos National Assembly approved a draft law towards the end of 2016 on the management of chemical substances. The draft has wide coverage and covers 4 categories of hazardous chemicals ranging from prohibited (category 1 to those which require licenses and approval. Hazards are based on GHS classification. The draft law also covers a wide range of activities. Implementation details are currently unknown, but will become effective within 120 days from the date that the President of the Lao PDR issues a Presidential Decree promulgating the law and 15 days after it has been posted in the Official Gazette. The situation will be closely monitored. EURASIAN ECONOMIC UNION (EAEU) According to the EEU Council s decision dated May 17, 2017, the Technical Regulation on Chemical has been adopted. The regulation will come into force as of under specific conditions i.e. the regulation will come into force only if requirements to the state Register and Order of Notification (i.e second tier legislation) is developed and comes into force before Due to the advocacy work conducted to date, the Kazakhstani side managed to achieve the binding of the entry into force of the main document with the adoption of the documents of the second level. By the national parts of the Register must be ready. Below is the link to the link to the legal text, for which a translation will become available. The Ministry of National Economy has promised to share the signed copies of the Technical Regulation and the Council s decision later. 7

10 The Eurasian Economic Commission s (EEC) department for technical regulation plans to send out the first drafts of the second-tier documents, including the procedure for formation and maintenance of the register of chemicals and mixtures and the procedure for notification of new chemicals and mixtures for review in early June After that, it is expected in mid- June the RoK s earlier established working group (WG) for formation of industry position will start working. Several GER member companies are involved in the working group. Registration: Kazakhstan officials understand the registration is a must for all substances and mixtures. However, if the substance/ mixture/ substance within mixture were not preliminary registered in the national registers, then no registration files will be created for them and they will be considered as new to the market. After June 2021 such substances will be subject to notification. The interpretation on mixtures is not totally clear, but it is thought that will be registered after notification of all the substances that are employed in them. This interpretation will be checked. SWITZERLAND The period for public consultation on the planned revision of the Chemicals Ordinance (ChemO) ended at the end of May Industry raised concerns on a number of issues including: - The planned notification requirements for intermediates - The planned notification requirements for the production of nanomaterials (no cut-off with regards to small volumes, small concentrations or relevance) - The planned notification requirements for the handling of nanomaterials (not substance specific, downstream users would be required to report "activities") A meeting with the Federal and Cantonal Authorities (enforcement agencies) as well as with NGOs and academia showed that the issues with regard to nanomaterials was echoed by academia. The enforcement agencies criticized the same points plus the fact that they lack the human and material resources to enforce the planned requirements. The Federal Office for Public Health (Bundesamt für Gesundheit, BAG) which has taken the lead in this endeavor has asked the industry for a meeting in early July to discuss possible ways forward. There has not yet been any indication that the originally announced timing (decision by the federal council late in 2017, enactment by 1 January 2018, with some grace periods for requirements) would be changed. TURKEY Turkish REACH, KKDIK was issued on in local language. There are some transition times for some applications. The registration will be made between The registrants must make a notification (pre-registration) until via the MoE webpage, However this is not yet functional. 8

11 UKRAINE The Cefic membership is again alerted to the fact that Ukraine s draft Technical Regulation for the safe circulation of hazardous chemicals in the internal market was published 21 October The text is in Ukrainian. The regulation is intended to enter into force on 1 January Advocacy work will commence once the translation becomes available. US Source: A Burr American Chemical Council (ACC). It is now a year since the LCSA was signed and EPA has been going through the regulatory process to finalize the framework rules to implement the changes to TSCA (e.g. public stakeholder meetings, seeking comments on draft rules, etc.). The rules published recently are: Inventory Reset Prioritization Rule Risk Evaluation Rule Initial 10 Scopes for Chemicals to undergo Assessment Risk Guidance ACC is expecting the Fees rule to be published later this summer. BRAZIL Assessment of Public Comments on Draft Regulation of Industrial Chemical Substances A Working Group under the National Commission on Chemical Safety (CONASQ) assessed alternative schemes from various countries, taking into account the lack of resources in Brazil. The Canadian model was seen as a good starting point. An inventory will be set up to provide a pool of substances for prioritisation. A subset will be selected for review by a technical committee formed from the Ministries of Environment, Health, Labour, and Industry. Manufacturers and importers will be requested to provide information on the substances, the technical committee will perform a risk assessment, with risk management measures (or other regulatory control measures) an outcome. At this stage it appears limited information would be required for setting up the inventory, and new substances would enter the prioritisation pool, rather than require upfront registration. Prioritisation criteria are proposed as Persistence, Bioaccumulation, Ecotoxicity, CMR, Endocrine Disrupters, relevant human health and environment exposure, and international alerts (note criteria appear to be more stringent than PBT). Establishing a new agency is not planned. Over 1000 comments have been received, which have been published on the Ministry of Environment s website. Some radical changes to the proposed legislation have been put forward in comments, with little guidance from the Ministries as to their intentions. The 9

12 Working Group will assess these and accept or reject them, however, progress has been delayed due to the political instability in Brazil. The first meeting of four is planned for 7 th July, with the aim, following approval from the respective Ministries, of sending the draft legislation to congress in early COLOMBIA Interpretation of Draft Decree. The Decree is only available in Spanish but available on request. Version: 0102_2017 Scope Registration of chemical substances for industrial usage. Risk evaluation to health and the environment and according to the specific usage Program for risk (health and / or environment) management. Industrial usage This refers to any transformation, formulation, consumption, storage, preservation, treatment, packaging, transfer, mixing, production of an article or any other use of chemicals in the industry. Registration All manufacturers and/or importers of industrial chemicals are requested to classify and identify the hazards of the substances according to GHS. Such a hazard identification and classification of the substance, the potential use of the substance in the country, as well as additional information determined by the competent authority, should be included in the Register of Chemicals for Industrial Usage by the manufacturer and / or importer. GHS has not been implemented in Colombia yet. The Colombia GHS draft regulation went through public consultation from December 15th to December 26th. According to article 28, the period for GHS implementation will be: Substances: 36 months and Mixtures 48 months form the publication in the Colombia Official Gazette. The deadline for Registration is January, There is no mention to a specific month nor day in the regulation. Self-assessments on risks to health and environment of chemical substances for industrial use (article 6, second paragraph): As of 2020, chemical substances for industrial use that are intended to be imported or manufactured should be registered. Those chemicals which fall under the classification as CMR, PBT or Acute (short-term) hazard to the environment, require environmental and health risk reduction management programs carried out by the manufacturer and / or importer. Self-assessment on risk to environment (article 7): All manufacturers or importers of chemical substances for industrial usage referred to in article 6 should undergo a selfassessment of risk to environment based on guidelines issued by the Ministry of Environment and Sustainable Development. Self-assessment on risk to health (article 8 ): All manufacturers or importers of chemical substances for industrial use referred to in article 6 should carry out the self-assessment of risk to health based on guidelines issued by the Ministry of Health and Social Protection. Inspection on self-assessment of risk to the environment (article 9): The National Environmental Licensing Authority (ANLA) may at any time require importers or manufacturers to submit their self-assessments of chemical environment risk in order to verify 10

13 its compliance with the provisions and in case of default will impose the preventive and sanctioning measures. Inspection on the self-assessment of risk to health (article 10) The Ministry of Health and Social Protection may at any time require importers or manufacturers to submit their selfassessments of chemical health risk in order to verify compliance with the provisions and in case of default will impose the preventive and sanctioning measures. Program for risk (health and / or environment) management (articles 11 and 12): All manufacturers or importers of chemical substances for industrial use referred to in article 6 should perform programs for the reduction and management of risk to the environment and/or health based on the guideline issued by the Ministry of Environment and Sustainable Development / Ministry of Health and Social Protection. Tasks and duties: Importers or Manufacturers (article 20) a) Integral management of chemical substances of industrial usage which it imports or manufactures; b) Identification, classification, labeling and Safety Data Sheet (SDS) of chemical substances for industrial usage, according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS); c) Provide information required by the Ministry of Commerce, Industry and Tourism through the mechanism defined for this purpose; d) Perform self-assessments of risk to environment and health of chemical substances for industrial use, in accordance with guidelines issued by the Ministry of Environment and Sustainable Development and the Ministry of Health and Social Protection; e) Develop and implement programs containing risk management actions to health and environment of chemical substances for industrial use, in accordance with guidelines issued by the Ministry of Environment and Sustainable Development and the Ministry of Health and Social Protection; f) Carry out the adjustments in the risk assessments and in the risk management programs for health and environment requested by the competent authorities; g) Prepare the annual report on compliance with the risk management programs for health and environment and make it available to the competent authorities; h) Submit the information required by the competent authorities with respect to the annual compliance report, using the mechanism designated for this purpose; i) Support and participate in research processes on risk management related to industrial chemicals; j) Comply with Decree 1079 of 2015 when shipping chemical substances of industrial use; k) Manage the waste of chemical substances for industrial usage as Decree 1076/