Global Emerging Regulations (GER) Network of Experts Quarter 1 Report

Transcription

1 Global Emerging Regulations (GER) Network of Experts 2018 Quarter 1 Report April 2018

2 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. 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 for damages of any nature whatsoever resulting from the use of or reliance on the information. 1

3 TABLE OF CONTENTS MAINLAND CHINA (PEOPLE S REPUBLIC) 3 SOUTH KOREA 4 JAPAN 5 TAIWAN 6 VIETNAM 6 PHILIPPINES 7 AUSTRALIA 7 COLOMBIA 9 COSTA RICA 9 EURASIAN ECONOMIC UNION (EAEU) 10 2

4 MAINLAND CHINA (People s Republic) As reported during 2017, the data requirements part of the Order 7 technical guidance has been updated and published, but not the full document. The new data requirements came into force on 15 th October in The Cefic membership is reminded of the changes, which include: - 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 no longer required for level 2 and above. - New waiving criteria for chronic toxicity and carcinogenicity introduced for level 4. The outcome of Order 7 compliance checks by local Authorities in the Shanghai area have not been made publically available, or to the Ministry of Environment Protection Solid Waste and Chemical Management Center (MEP-SCC). The CEFIC membership is once again reminded 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 chemical substances in China. This is probably one of the reasons why the full guidance document has not been updated. The Chinese Ministry of Environmental Protection (MEP is drafting a new regulation called Regulations on Environmental Management of Chemicals to cover both new chemical substance management and existing chemicals management. 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). On 29 th December 2017, MEP published the Catalogue of Priority Chemicals (1st Batch) and outlined the risk control measures on these chemicals. On the same date MEP also published the Inventory of Severely Restricted Toxic Chemicals (2018) together with the instructions on the Notification for Customs Clearance for Importing/Exporting Toxic Chemicals. In a recent development, it was announced the MEP will be renamed as the Ministry of Ecology and Environment (MEE), responsible for environmental management of new chemical substances and existing chemical substances. In addition, the State Administration of Work Safety (SAWS) and Fire Service Department will be consolidated into a new ministry called the Ministry of Emergency Management, taking the lead for hazardous chemicals management. 3

5 SOUTH KOREA On 20 March 2018, Korea s Ministry of Enviroment (MoE) announced the adoption of amendments to the Act on Registration and Evaluation etc. of Chemicals (K-REACH), along with the enactment of the Consumer Chemical Products and Biocides Safety Act (K-BPR). These enter into force on January 1, K-REACH in summary: Requirement to register all new (non-kecl listed) substances above 0.1 ton per year, and to notify the production or import of any amount below this threshold; New requirement for the registration of all existing (KECL listed) chemical substances over 1 ton per year; It is required to additionally register the chemical hazard information of CMR substances over 1,000 tons per year; Pre-registration of existing substances will support the joint registration for companies that manufacture or import the same existing chemical substances; Mandatory information includes chemical name, use, content, hazard information, and exposure information; Strict penalties are imposed on the manufacture, import, or sale of hazardous chemicals without registration; Some substances or uses (e.g. R&D substances, export only, polymer of low concern) are exempt from registration. However, a confirmation on exemption must be applied for. K-BPR in summary: MoE approval is required for biocidal active substances; MoE approval is required for new biocidal products; whilst biocidal products already on the market need to be notified to authorities; Labeling requirements apply (biocidal active, use, risks); Treated articles must make use of approved biocidal actives, and biocidal chemicals information must be disclosed on request. If claims on biocidal properties by the article itself are made, labeling requirements as above apply. Timelines: June 1, 2018 pre-registration starts; June PEC substances to be jointly registered; After June 2018 Annual Reporting is abolished however continues until June 2018; January 1, 2019 K-REACH and K-BPR become effective; December 31, 2021 Registration grace period for CMR substances above 1 ton ends; December 31, 2021 Registration grace period for existing substances above 1000 tons ends; December 31, 2024 Registration grace period for existing substances above 100 tons ends; December 31, 2030 Registration grace period for existing substances above 1 ton ends; The chemical industry has raised concerns regarding CBI and avoidable burden to both the industry and the authorities: Submission of complete composition information is required, including non-hazardous ingredients. As all SDS are already submitted, hazard information is readily available, and the full composition is of no evident value for safety; Generic names on SDS to mask chemical identity have to be (re-)applied for every 3 years. In addition, they apply to products rather than substances, leading to redundancy; 4

6 Cut-off limits for very low concentrations should be in place (in analogy to EU CLP); Redundancy between the authorities MoEL and MOE should be reduced, by aligning the independent acts K-REACH and ISHA JAPAN The following relates to the latest consultation for amendments to the implementation of CSCL. It appears that a period for comments was open until March: There has been another public comment for modification of the Implementation note, which is the essential guidance to judge ENCS status of chemical substances. There are two major modifications: 1. Clearly stated rule for ENCS status of onium salts compounds. Customarily addition and/or onium salts between existing chemical substances except heavy metals have been regarded as existing chemical substances. This concept will be clearly explained in the implementation note % polymer rule In addition to the currently available 99% and 98% rule, a new definition of existing chemicals for polymer will be available. The current rules are as follows; 99% rule: More than 99% of existing polymer with less than 1% of monomer of new/existing substance can be regarded as an existing chemical substance. 98% rule: More than 98% of existing polymer with less than 2% of monomer as an existing substance can be regarded as an existing chemical substance. New 90% polymer rule Those polymers consist of more than 90% of existing polymer and less than 10% of other monomers, industry can use the ENCS Number of 90% polymer regardless of the rest of less than 10% constituents when they meet all the conditions from 1-6 below: 1. Each monomer (missing from the existing polymer listing) should be less than 2% and those monomers are existing chemical substances, or less than 1% of new chemical substance 2. Not containing any chemical structures resembling with Class 1, Class 2 Specified chemical substances 3. As for metals, Na, Mg, K, Ca are acceptable, but should not contain any other metals in chemical structure. 4. The fundamental body part of organic polymer doesn t show cationic character 5. Should not contain As, Ce 6. The following functional group(s) should not be present Carbon-Carbon double bond Carbon-Carbon triple bond Carbon-Nitrogen double bond Carbon-Nitrogen triple bond Aziridine group Amino group 5

7 Phenol hydroxyl group Fluoro group And those polymers having more than 10,000 of number average molecular weight (Mn), and consist of more than 90% of existing polymer and less than 10% of other monomers, industry can use the METI-code of 90% polymer when the rest of less than 10% of constituents meet conditions 1-5 above. In other words, restriction 6 for functional group is removed if Mn is 10,000 or more. However, if any chemical structure resembling with Class 1 and/or Class 2 Specified chemical substances has been contained, those polymers cannot be regarded as existing substances under 90%, 98%, and 99% rules. Two further proposed changes to CSCL being posted for public are as follows: These were issued on February 28 th relating to modification of study methods / assessment standards for CSCL notification. Modified ordinance will be issued by the end of March, effective date is to be April 1 st of this year. 1. Biodegradation study: Introduction of TG301F in addition to TG301C. Assessment standard for both methods will be updated. 2. Fish accumulation study: Introduction of modified TG305 and modification of assessment standards. 3. Mutagenic study: Modification of TG473 and introduction of TG490 (for risk assessment). Modification of assessment standards for Chromosomal ab. Study and TK test. 4. Polymer scheme: Mitigation of some test items e.g. deletion of ph1.2 and 7.0 test levels for stability study, deletion of n-octanol, heptane for solubility study etc. URL (in Japanese) TAIWAN The Network has received and reviewed Taiwan s Amended Guidelines on Regulated Toxic Chemical Substances and the Management of Their Handling, These amendments fall under the Chemical Substances Control Act. VIETNAM With regards to the compilation of an existing chemicals inventory the acceptance of public comments and nominations for the Inventory ended in December No further nominations are accepted since then. The Vietnam Chemicals Agency (Vinachemia) is now working on the list and the developing supporting tools for self-checking the correctness of the final list. It is anticipated that a tool will soon be available to allow companies to check if all their nominations were accepted. 6

8 Decree No. 113/2017/ND-CP (Law on Chemicals) has been published. This includes 5 annexes of chemicals requiring control measures. PHILIPPINES A Cefic-GER sub-team has been working with the Philippine Authorities on the DENR-EMB RA6969 reviews. Positions have been submitted and questions raised in order to try to bring clarity on 4 key issues: 1. Confirmation of the Polymer Exemption Criteria based on recent proposed updates to the relevant guidance documents 2. Administrative requirements for Polymer Exemptions as they relate to the need to make applications, CBI issues and potential onerous requirements. 3. Small Quantity Import Petition requirements that impact the ability to undertake R&D 4. Possibilities of having authority published guidance on PMPINs PICCS eligibility criteria Developments will be reported in due course. AUSTRALIA NICNAS Reforms; The aims of the reforms remain to: make regulatory effort more proportionate to risk promote safer innovation by encouraging the introduction of lower risk chemicals continue to protect the Australian people (both workers and the public) and the environment from any harmful effects of industrial chemicals. Following several consultations the Commencement of the new Australian Industrial Chemicals Introduction Scheme (AICIS), has been deferred until 1 July They are currently seeking comments on the following drafts; Industrial Chemicals (General) Rules 2018 (General Rules) Industrial Chemicals Categorisation Guidelines (Categorisation Guidelines) Industrial Chemicals (Consequential Amendments and Transitional Provisions) Rules 2018 (Transitional Rules) Available: The public comment period closes on Friday 4 May 2018 at 5pm Australian Eastern Daylight Time (AEDT). Comments can be made online or by post. 7

9 Particular points of change to note since the last consultation in July 2017 are detailed by NICNAS here: A summary of the points in the document are below; Changes to categorisation terminology Exposure band terminology o Chemicals with end uses that will result in intentional human exposure are no more explicitly referred to as industrial chemical is for an end use in cosmetics, tattoo inks or personal vaporisers o Terminology changed for the concepts to determine the environment exposure band, also now included are specific details on the reduction factors (previously referred to as release factors) which are specific to substance end use. Circumstances in which an industrial chemical is in a particular introduction category o Additional circumstances in which introductions are not exempted or reported, also modified criteria for some circumstances (certain industrial chemicals at the nanoscale) and those which were previously captured in hazard bands (certain fluorinated organic chemicals) o Introduction of low concern biopolymer now included as introduction which are exempted o The proposal on the 2% rule for comparable listed polymers has been amended to be similar to the current polymer 2% rule under exemptions o Modified criteria for some exemption circumstances (comparable to already listed industrial chemicals, certain chemicals at the nanoscale). Also included those which were previously captured in exposure band criteria (imported and subsequently exported, solely for use in research and development). Internationally-assessed introductions o Risk assessment conducted for the purposes of the EU Biocidal Products Regulation were included in the list for internationally-assessed introductions o Outcomes are specified for introductions that meet the cuirtiera of having been internationally-assessed. Exposure Bands o There are 3 human health exposure bands in place of the previous 5 o There are 4 environment exposure bands in place of the previous 4 Hazard Bands o There are 3 human health hazard bands in place of the previous 4 o There are 4 environment human hazard bands in place of the previous 5 Specified classes of introductions o Some definitions and information requirements have been changes. o Certain classes of introductions cannot be categorised as exempted; UV filter intended to protect the skin Certain industrial chemicals that have an end use in an article with food contact Highly branched organic chemicals Industrial chemicals that have an end use as a biocide Certain polyhalogenated organic chemicals 8

10 Hazard information requirements o Introduction to the guidelines to consider hazard information about known environmental degradants o Changes to hazard information requirements which are intended to make them more accurate, appropriate and understandable. Pre-introductions report requirements o Split for requirements that apply to all reported introductions with some additional requirements for specific types of reported introductions. Annual declarations o Consolidated requirements to these declarations Record keeping requirements o More explicit details are given on requirements for categories of introduction Commercial evaluation introductions o Introduction of a volume of an industrial chemical under a commercial evaluation authorisation must not exceed 10 tonnes over the period for which the authorisation is to be in force. The situation continues to be closely monitored and if appropriate comments will be submitted. COLOMBIA The Network has received Information regarding Environmental Risk Assessment and Inventory in Colombia. The documents are available from Cefic on request The 2 documents in question are: 1. Terms of reference for the environmental risk assessment (ERA) of chemical substances for industrial use in the country (in Spanish only). 2. Input data for the construction of the national inventory (excel, in Spanish only). COSTA RICA The Network has received a document that provides updated information on the registration and notification of chemical products in Costa Rica. The Technical Regulation will enter into force in May The document is available from Cefic on request. 9

11 EURASIAN ECONOMIC UNION (EAEU) Update on EAEU Technical Chemical Regulation advocacy The EAEU regulation should come into force as of July 2021, as long as the secondary level documents come into force by December Contact with Russian Authorities: Major multinationals met with the Russian Ministry of Manufacturing (the developers of the Chemicals Legislation) and passed on all their concerns and key messages. There are positive signs. The Russian Ministry of Industry and Trade have proposed that the following research "Development proposals on the application of best practices of international cooperation in the preparation for the implementation of technical Regulations of the Eurasian Economic Union "On Safety of chemical products to be included into the Plan of Scientific Research of the EAEU Commission for The development of the Secondary Level Text is now underway, and we are actively part of the working group writing the text. Content of our advocacy on the 2 nd tier documents: Through direct advocacy with Kazakhstan Authorities, the group ensured that the Kazakh Government understood the risk of the current first level draft legislation to business. As a result, the Kazakh Government officially notified the Eurasian Commission that the EAEU regulation On Safety of Chemicals should only be adopted should they accept certain amendments including: A 1 t/y/le threshold for the registration of new substances (except CMR Class 1), A 100 kg threshold for registration of new CMR Class 1 (this was found as a compromise to avoid the original proposal to register of all new chemicals regardless of threshold/volume) Registration of only those mixtures that contain CMR Class 1 with a gradual introduction as per in 10 years from law publication (this was another compromise which was negotiated to avoid immediate registration of all mixtures regardless of volume/threshold) Inclusion of the information from credible sources into the Customs Union Registry of chemical products (to have as many existing substances as possible in the EAEU inventory) ; The possibility to use information from open sources (publications, databases) with the aim to avoid unnecessary testing. In an effort to speed up the adoption of EAEU Chemical regulation, Russian Government adopted a separate National Technical Regulation on the Safety of Chemicals that should come into force as of June However, nobody is working on Registry and Notification rules at the national level, so it is expected that national regulation will be repealed. 10