GER 2019 Quarter 2 Report

Global Emerging Regulations (GER) Network of Experts

2019 Quarter 2 Report

July 2019

GER 2019 Quarter 2 Report

This report covers those non-EU countries where regulatory reform has occurred or continued during quarter 2 2019. 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.

GER 2019 Quarter 2 Report

TABLE OF CONTENTS

ARGENTINA 1

AUSTRALIA 1

BRAZIL 2

CANADA 2

CHILE 2

EURASIAN ECONOMIC UNION (EAEU) 3

INDIA 4

INDONESIA 4

KENYA 4

MAINLAND CHINA (PEOPLE’S REPUBLIC) 5

MALAYSIA 6

MEXICO 6

MIDDLE EAST 6

NEW ZEALAND 7

SOUTH KOREA 7

SRI LANKA 9

TAIWAN 9

THAILAND 10

TURKEY 10

US 10

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ARGENTINA

As previously reported, Brazil and Argentina signed a MoU for bilateral cooperation on chemicals management during a meeting of the XXI Forum of Ministers of Environment of the Latin American and Caribbean (LAC) region in October 2019. Argentina published the first draft of their chemical regulation last year. This is similar to Brazil's draft law. Although the draft was submitted to WTO it was withdrawn on 17th June for reasons which are currently unknown. It is thought however that this could have been due to a need to update. On 11th June, The Argentinian Secretary of Environment and Sustainable Development published the final version of the Argentinian Chemical Draft Bill.

AUSTRALIA

AICS Reforms: From 1 July 2020, NICNAS will be replaced by the Australian Industrial Chemicals Introduction Scheme (AICIS). The ban on the use of new animal test data for ingredients solely used in cosmetics will also begin on 1 July 2020.There are no current open consultations on the implementation. The remainder of the General Rules are being developed taking into account the stakeholder feedback received on the exposure drafts in 2018. Questions on the new scheme are available with answers at and the option to submit new questions to be answered at: https://www.nicnas.gov.au/New-scheme-1-July-2020/ask-a-question-about-the-new-scheme It should be noted however that early regulatory changes are now in effect. Specifically, these are:

• no more annual reporting for permit holders and self-assessed assessment certificate holders • shorter timeframes for Approved Foreign Scheme assessments • polymers of low concerns (PLCs) are exempt from notification (notification is not required but

record keeping and annual reporting requirements are in place) • expansion of the PLC criteria • changes to the definition of a new synthetic polymer • no more Safety Data Sheets (SDS) and labels required for cosmetics introduced at low volumes

More details on the specifics can be found at: https://www.nicnas.gov.au/New-scheme-1-July-2020/Early-commencement-whats-already-changed-for-importers-and-manufacturers IMAP: IMAP Tranche 27 opened for public comment on 28 June 2019 and is available for public comment until 23 August 2019.

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BRAZIL

There have been few developments noted since the report given in quarter 1. Reports were made in the media in April this year that Brazil’s environment minister had “shelved” the country’s draft chemicals bill, which aims amongst several provisions, to introduce an inventory as well as prioritized risk assessment of existing substances. The bill had been submitted, and was awaiting review, but apparently was returned to the Ministry of Environment to make further changes. Shortly thereafter, the government stated that this was incorrect and that the bill is indeed still being reviewed, but there remains no clear timeline for when it will be resubmitted for approval and passing on to Congress. It was noted that the Brazilian Government are engaged in becoming full OECD members.

CANADA

It is planned to update the Canadian GHS provisions with the US: Under the Regulatory Cooperation Council (RCC) Joint Forward Plan, Canada and the United States committed to “work together to coordinate the adoption of future updates of the GHS to facilitate common approaches and synchronized implementation in Canada and the United States”. In order to continue to ensure alignment between the respective hazard classification and communication requirements for workplace chemicals in Canada and the United States, Canada will make necessary updates to the Hazardous Products Regulations. The objective of the amendments to the Hazardous Products Regulations is to incorporate changes adopted in the 6th and 7th revised editions of the GHS, as well as to amend certain provisions of the regulations to provide greater clarity. It is important to note that Canada will continue to maintain the current level of worker protection that currently exists. In addition, the CMP (Chemical Management Plan) – is on track e.g. by governmental publications of draft and final screening assessments of substance groups and individual substances. Relevant news is published on the Health Canada website: https://www.canada.ca/en/health-canada/services/chemical-substances/latest-newshtml

CHILE

On October 26, 2018 it was announced that Chile’s environment and health ministries had approved a proposed draft regulation for the classification, labelling, and notification of chemical substances and mixtures. The regulation would implement the GHS and would have provisions for classification, labelling and packaging along the lines of the EU CLP Regulation. It would also have various notification requirements.

The draft is still pending and needs to be approved by the president. After this, it will be published in the Official Gazette of Chile, providing for a transitional period before entry into force. The regulation is expected to be officially published end of 2019 beginning of 2020.

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EURASIAN ECONOMIC UNION (EAEU)

The EAEU Chemical Technical Regulation is now expected to be published by the end 2021 or early 2022, not June 2021 as previously expected.

The Russian Chemical regulation has been terminated In accordance with Government Decree #761 dated on 14.06.2019, signed by the Prime Minister and published, the Russian Technical regulation On Safety of Chemicals is now terminated i.e. it is now invalid). On May 14, 2019 the adoption of documents of the second level was cancelled due to the position of the Kazakhstan Government, which considered it premature to accept documents of the second level until the situation with respect to changes to the first level document was clarified. A formal instruction of the EAEU Council to the Kazakhstan Government to lead the development of changes to the first level document is still to be signed by the Russian side. There are large discrepancies between the text of the second level documents submitted for the adoption on the board meeting and the text that passed regulatory impact assessment procedure. In particular, more than 430 restricted for use substances in Annex 7 and changes in Annex 8.

On June 14 the EAEU member countries authorities had a meeting with EAEU Commission on the secondary level documents. Kazakhstan's side participated from Astana via teleconference. The key outcomes from which are as follows:

1. List of the restricted for use substances (Annex 7). This is a full list of IARC classified substances which could lead to permit registration being more onerous and complex, with the possibility that the registration files may have to remain inappropriately classified. It has been recommended to substitute the EAEU list of restricted for use substances with the REACH list of CMRs class 1&2. However, this suggestion has been rejected as they are against binding to data from the European Union only. However, consistency is required as the Technical Regulation on chemicals is based on GHS. Chemicals provided in Annex 7 should also be based on GHS and not on different the classification system as used by IARC. It is understood that the only list of classified substances based on GHS, which has been reviewed in detail with significant data and a transparent process is the EU list of EU list of harmonized classification.

2. Exclusion of mixtures and threshold. Industry is still fighting to avoid registration of all mixtures by proving that not all mixture/products are registered in other countries as certain parties believe.

Inventory of Existing substances. The requirements of the Regulation will include the need to notify any new substances which are not on the inventory of existing substances. This notification process will be very demanding i.e. many new tests are required, beyond REACH, regardless of the level/volume of new substance manufactured/imported (even <1t/y; there is no de minimis threshold).

• As previously indicated, industry can submit their substances manufactured or imported as such or in mixture (regardless of their level) to the Russian authorities between August 10, 2019 and before December 31, 2019 (based on our current understanding) in order to appear on the EAEU Inventory of existing substances. Process to submit this notification to Russian Authorities is described in Annex 1. Template form may be downloaded here: http://ciscenter.org/tabstest/pattern.php Timelines of EAEU/Member States Inventory of existing substances is provided in this link.

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• Please note that: Monomers of polymers should be listed on the inventory of existing substances to avoid notification. Even though polymers are out of “Notification of new substance” scope, some experts are encouraging industry to put polymers on the inventory as well in case this changes. Even though cosmetics are also out of scope of “Notification of new substance”, to our knowledge raw materials and intermediate mixtures used to manufacture cosmetics are in scope.

• In addition, based on current information, if a company imports a substance to several EAEU countries, there is no need to submit this substance to the inventory of each EAEU country i.e. it is sufficient to ensure that the substance is on the inventory of one country as there will be a unified inventory at the end.

In an attempt to obtain further clarification, the Cefic GER is preparing a list of questions to the EAEU authorities. The situation continues to be critically monitored.

INDIA

It was expected that the draft of India’s National Action Plan for Chemicals (NAPC) by the Hazardous Substance Management Division of the Ministry of Environment, Forest & Climate Change would have been published for public comments by now. However, so far this has not materialised. The NAPC has been ongoing since 2012 and discussions are still in progress.

Cefic has sent comments via ICC on India’s Proposal to make BIS (Bureau of Indian Standards) Standards mandatory for certain Chemicals and Petrochemicals. The key drivers for the proposal to make 17 chemical & 24 petrochemical standards mandatory are to address protection of safety, health & environment, protection of national security as well as prevention of unfair trade practices.

INDONESIA

The only progress to report since the quarter 1 report is that the president has signed Government Regulation Number 31 Year 2019 regarding the implementation of Law Number 33 Year 2014 regarding Halal Product Assurance. The regulation is enacted on 3rd May 2019.

KENYA

To remind the Cefic membership, Kenya is preparing to implement a chemicals management regulation. A bill could be in force within a year. The regulation will also see Kenya aligning itself with the seventh edition of the GHS, which will be mandatory.

A copy of the draft regulations is available on request. Cefic has submitted an exhaustive list of comments.

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MAINLAND CHINA (People’s Republic)

IECSC The Cefic membership should be aware that China has formally re-opened the IECSC to chemical substances manufactured or imported in China prior to 15 Oct 2003. The deadline to submit applications to the Chinese Ministry of Ecology and Environment (MEE) is 30 Sept 2019. This is an opportunity to get unlisted substances, which may have been overlooked when the inventory was formed in 2003, added to IECSC without going through new substance notifications. A wide range of evidence to demonstrate that a substance has been manufactured or used in China prior to 15 Oct 2003 is now accepted.

• Sales invoice • Import and export customs declaration • Industry association statistics report • Chemical yearbook • Official document issued by government body • Public publication and all other supporting documents

The notice also mentions that the MEE will strengthen the penalty for those who fail to notify new chemical substances afterwards. The official MEE notice and further details on submission process are available here (Chinese): http://www.mee.gov.cn/xxgk2018/xxgk/xxgk06/201906/t20190628_708006.html Environmental risk assessment It has also been reported that the MEE-SCC have issued a notice to solicit public comments for a list of 23 existing substances for further environmental risk assessment. The information shall include physio-chemical properties, environmental and health related toxicity data, tonnage of manufacture and use, use and production, environmental exposure data, etc. Information can be submitted to chemicals@mepscc.cn by August 31, 2019. Data in electronic format is preferred, but the materials can also be sent to the SCC address. The full list of mostly SVHC substances can be found here: http://www.mepscc.cn/zhxx/tzgg/201905/t20190527_704262.shtml

Order No. 7 China’s Ministry of Ecology and Environment (MEE) has opened a consultation of a draft revision to MEP Order No. 7. The deadline for this consultation is August 16. The consultation details can be found here: http://www.mee.gov.cn/xxgk2018/xxgk/xxgk06/201907/t20190711_709145_wap.shtml In brief, the revision covers the following points:

• For notifications the following changes have been proposed: <100kg is changed to a full exemption, <1t/year is changed to record keeping only, and 1-10t/year is reduced to simplified notification.

• Downstream users would be newly permitted to carry out notifications for certain uses. • New substances which were found to be PBT, vPvB, or of “equivalent concern” would require a

socio-economic analysis justifying their use prior to approval. • When listing such “substances of concern” on the inventory, the use would be limited to only

those uses. New uses would require registration.

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• The 5 year start date for addition to the inventory would change from first manufacture/import to the notification approval date.

• Reduced scope of notifications subject to annual reporting. Further changes to data requirements may be published in separate guidance.

MALAYSIA

Department of Occupational Safety & Health A short consultation period was opened in April on the DOSH proposal to add ~400 chemicals to the list of mandatory classification under the Industry Code of Practice on Chemicals Classification and Hazards Communication (ICOP) under the CLASS Regulations (GHS regulations). The proposed classifications were largely aligned to the EU CLP Annex VI. However, the proposals did not include the ‘self-classification’ of additional hazards or the ‘minimum classification’ concept that is embodied in the CLP. DOSH hopes to finalize the proposal by the end of the year. Separately, the revision of the CLASS Regulation is still pending approval. Department of Environment Public consultation and feedback on the proposed Environmental Protection Act is on-going. This Act will replace the Environmental Quality Act 1974. Key objectives/highlights include:

• Mainstreaming environmental protection, strengthening the act and modernizing. • Increasing fines and penalties. • Addressing e-waste & end-of-pipe control technologies.

Due to substantial feedback from civil society, the draft may undergo additional significant changes.

MEXICO

In quarter 1 it was reported that Mexico's National Institute of Statistics and Geography has published a notice of guidelines for the creation and use of a national catalogue of chemical substances. Mexico aims to create the catalogue from the National Inventory of Chemical Substances 2010-2013 and the country's 2011 non-mandatory adoption of the UN's Globally Harmonized System (GHS) for classification and labelling of chemicals for mixtures. The guidelines establish the specifications, general dispositions and recommendations for how the catalogue should be used.

The situation as to how all this will develop is unpredictable.

MIDDLE EAST

It has become apparent that the deadline for phase 2 and Phase 3 with regards to the registration of plastic packaging is set for 1st of September 2019, rather than April 1st, 2020. https://www.saso.gov.sa/en/Certification/Certificates_of_conformity/Pages/Registration_of_plastic_products.aspx Both the EU and US have raised concerns to this point: https://www.wto.org/english/news_e/news19_e/tbt_07mar19_e.htm

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“11. Saudi Arabia –degradable plastic (OXO) The European Union, supported by the US, expressed concerns with Saudi Arabia's new regulation requiring certain types of disposable plastics to be "OXO-degradable" and bear a specific mark to demonstrate compliance. The EU said that it appreciates Saudi Arabia's efforts in environmental protection, but it urged the kingdom to postpone the implementation of this measure until further scientific studies regarding the real environmental benefits of OXO-degradable plastics have been finalised and further exchanges on this matter have taken place. Saudi Arabia said that it will delay the implementation of this measure until September 2019. Saudi Arabia said it launched a national study on the adverse impact of plastics on the environment, and asked the EU to provide any recent studies on this matter”.

NEW ZEALAND

It is understood that there are plans to update to the New Zealand Inventory of Chemicals (NZIoC). A spreadsheet of all chemicals on the Inventory can be found on the webpage (see below). Note: this list includes the chemical status but does not include any restrictions on its use. The search function on the webpage can be used for this information. June 2019 updates (including notifications finalised by February 2019) are given in the following document: https://www.epa.govt.nz/assets/Uploads/Documents/Hazardous-Substances/Guidance/cf92e137f8/NZIOC-Update-June-2019.xlsx A complete listing of the NZIoC can be found via: https://wwwepa.govt.nz/assets/Uploads/Documents/Hazardous-Substances/Guidance/044820bd71/NZIOC-Spreadsheet-June-2019.xlsx

SOUTH KOREA

The revised AREC, aka K-REACH, and K-BPR are final and in force. The following information may be of interest to the Cefic membership: K-BPR End of June 2019 was the timeline for pre-registration of existing biocides. Preservative in treated product has been debated. The previous comment from the authorities indicated that preservatives contained in raw materials are not in the scope of pre-registration since preservatives have no biocidal functionality. However according to recent briefing, this is no longer confirmed. The authorities will return the pre-registration, if the material is not relevant to pre-registration, i.e. out of K-BPR scope although the return is not clearly mentioned in law and guidance. Also, under KBPR there is some confusion about what to do for treated articles and whether or not in-situ biocides are in scope or not. AREC The pre-registration of existing chemicals was by the end of June. After the deadline, some period will be given to supplement the submitted information. In case foreign manufacturer or producer delays to provide information and does not assign a Korean based OR, the material can be still applied with

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following document. 1) document that confirms that all information will be secured by September 30 and submitted. 2) confirmation of effort that the import company is trying to secure information from foreign manufacturer or producer. UVCB substances not listed in the existing chemical inventory or substances produced as intermediates in the process may also be pre-registered where they satisfy the ME notification no.2019-82.

Existing chemicals to be subjected to registration (510 substances) are not applicable to the pre-registration of existing chemical. Therefore, it should be registered already if the manufacture or import is planned more than 1ton/yr. Letters of Access should be obtained for the registration. CCA (amendment draft) The Chemical verification number has to be provided to whoever is involved in sales, export or storage of the chemical. Chemical verification number is given when a company notifies imports or manufactures chemicals (it is also called chemical import/manufacture notification). For hazardous chemicals (toxic, prohibited chemical, etc. which are regulated by law) the verification number shall be marked to packages or containers. Marking to contract, invoice, SDS, a copy of import/manufacture notification certification, etc. can also be used in case of general chemical. ISHA Whilst Occupational Safety and Health Act (OSHA) was fully amended and promulgated on January 15, 2019, its subordinate ordinance (draft) was released on April 22 and contained additional details on SDS submission needs. Of importance is that: Manufacturer/importer has to submit SDS to authorities’ system if the chemical is hazardous. After submission of SDS, IT system issues specific number for each submission. This number has to be printed to SDS. If a chemical is non-hazardous and not disclosed to Sec 3 of SDS, the chemical name and contents have to be submitted to MoL separately. Non-hazard confirmation issued by foreign manufacturer can be submitted instead of the chemical information, if the chemical information cannot be disclosed to the importer. The submission of SDS has to be done before import/manufacture of the chemical. UVCB A new guideline on pre-registration in Korea has become available. In summary, MoE had just notified this guideline on June 7th and requires importers to pre-register UVCB substances by June 30, 2019. According to the guideline, the following substances shall be pre-registered by June 30: 1. UVCB substances not listed in the existing chemical inventory (ME notification no.2019-82) or substances produced as intermediates in the process. * The UVCB substances are imported or/and manufactured before 1991 but not listed in the existing chemical inventory, that 44,583 substances are listed. * Required dossiers related to UVCB: 1. description of the process including manufacturing and synthesis methods 2. information on known constituents in the final product (submit name, content, classification and labelling etc. as much as possible) * Submit analytical data such as chromatography if you own them * Submit information on major constituents more than 10% or CMR substances 1. document verifying to be manufactured, imported or used before 1991 2. information on CMR substances to be registered by 2021, and on the classification and labelling

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* submit the above information as much as possible 1. An importer who asked suppliers pre-notification or chemical identification but could not receive any response or cannot complete by deadline needs to submit the form with related information to the government agency (KECO) by email kreach2@keco.or.kr * 1. Fill in the form attached with as much information as possible. * 2. Submit evidence to confirm efforts to obtain missing information such as email communication * 3 Submit plans to submit future pre-notification Link for the guidelines: https://www.chemnavi.or.kr/chemnavi/spboard/noticedetail.do During ChemCon week Cfeic together with reps from JCIA, SCIC and ACC and ECCKs JWG met with KMoE Chemical Policy division in June to discuss our co-signed letter from earlier in the year as it related to K-REACH issues and practical implementation together with how industry has addressed some of the challenges within EU REACH. It included industry’s aim for global alignment (QSAR etc.) and regulatory cooperation in other countries.

SRI LANKA

It has come to Cefic’s notice that a draft national policy for chemicals management is expected in the coming months. According to commercial sources, if ministers agree the policy it will then be sent to the country’s parliament for approval. The main points in the policy will include rules on:

• imported chemicals inspection;

• labelling;

• transportation;

• storage; and

• hazardous facilities management. The environment ministry has been working on the policy with support from the UN and the International Council of Chemical Associations.

TAIWAN

It was noted that English translations for the two new chemical acts, reported in the quarter 1 report are now available: Toxic and Concerned Chemical Substances Control Act, 1/19/2019 https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=O0060012 Regulations of New and Existing Chemical Substances Registration https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=O0060043

The two acts in question are:

The new Toxic and Chemical Substances of Concern Control Act (TCSCCA), previously known as the Toxic Chemical Substance Control Act (TCSCA), was promulgated under the President order on 16 January 2019. And the Taiwan EPA published the revised the “Regulation of New and Existing Chemical Substances Registration” on 11 March 2019.

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THAILAND

The revision to the Hazardous Substance Act was approved in April and will come into force on 27 October 2019. Key changes are (1) the simplification of processes for transboundary shipments and (2) re-imports and re-exports no longer have to undergo re-registration. However, transboundary shipment of Type 4 chemicals (banned) are also prohibited. Separately, the first public consultation on the draft new Chemical Act was also held in April. This is a high-level framework law with key principles that include:

1. Protection of human health & environment; promotion of sustainable development 2. That all chemicals are managed (substances, mixtures, articles) 3. They are managed through the entire life cycle 4. Continuous improvements of the chemical management system through 3 committees

The law has provisions for a chemical inventory and restrictions based on evaluation of the chemicals. It also provides for extended producer responsibilities for used packaging materials. It is expected to be submitted for approval in 2020 and implemented in 2021.

TURKEY

KKDIK or Turkey REACH came into effect at the end of 2017. It requires pre-registration by end of 2020 and registration by end of 2023. The pre-registration builds on the previously submitted entries into the classification and labelling inventory under Turkey’s SEA (CLP) legislation. These entries have been transferred into the pre-registration portal. Manufacturers and importers are advised to review their SEA submissions and align them with the KKDIK pre-registration requirements. Also, communication with suppliers should start to understand whether they intend to fulfil their registration obligations under KKDIK. The pre-registration system appears to be progressing smoothly.

US

The US EPA published a list of 40 chemicals to begin a prioritization process which is the initial step in a new process of reviewing chemicals under the amended Toxic Substances Control Act (TSCA). The twenty high and low priority chemicals can be found in the link https://www.epa.gov/newsroom/reaching-another-tsca-milestone-epa-identifies-40-chemicals-prioritize-risk-evaluation

Proposed significant new use rules (SNURs) have been signed by EPA for 8 chemical substances undergoing premanufacture notice (PMN). These can be found in the Federal Register https://www.regulations.gov/document?D=EPA-HQ-OPPT-2019-0263-0001 – comments before 11 July 2019

An EU consultation has begun with the US to further develop regulatory co-operation.