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

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Page 1: Global Emerging Regulations (GER) Issue Team - …chemspain.org/.../05/Global-Emerging-Regulations-Report-Q1-2016.pdf · Global Emerging Regulations (GER) Issue Team ... Data requirements

Global Emerging Regulations (GER) Issue Team

2016 Quarter 1 Report

May 2016

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This report covers those non-EU countries where regulatory reform has occurred or continued

during Quarter 1 2016. 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 2014 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 (Dr. Adriana Jalba, [email protected])

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.

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TABLE OF CONTENTS

MAINLAND CHINA (PEOPLE’S REPUBLIC) 3

JAPAN 4

SOUTH KOREA 4

TAIWAN 6

INDONESIA 7

MALAYSIA 7

THAILAND 8

AUSTRALIA 9

NEW ZEALAND 9

SWITZERLAND 9

US 10

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MAINLAND CHINA (People’s Republic) Following a recent Chinese industry meeting the following update is provided: IECSC Supplementation The Inventory will only be re-opened for substances that were manufactured, imported or used in China before 15th October 2003.

MEP-SCC seems to be willing to accept industry’s proposal to consider all possible evidence and proof. They admitted that it is difficult to gather original receipts (invoices, etc) from more than a decade ago.

MEP-SCC is unable to provide definite timeline on when the official announcement will be made because approval from the minister is needed; however, industry can start gathering evidence now.

MEP-SCC plans to change IECSC supplementation procedure. Previously, all applications were submitted to local environmental bureau first and then passed to MEP-SCC. The new procedure could be that all applications are submitted to MEP-SCC directly. The Local Environmental Bureau is still involved and is only responsible for checking the validity of evidence submitted.

There are some errors (substance name, spelling, CAS no.) in IECSC. If any errors are found, industry can submit relevant information and evidence to the chemical management department of MEP-SCC without waiting for the official announcement on the re-opening of IECSC.

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 soon be released. China MEP Order 7 Guidance

The publication of the new MEP order number 7 guidance may be delayed until October 2016 because of the need to follow WTO procedure to notify it to WTO first before it can become effective.

Data requirements for toxico-kinetics and chronic toxicity are adjusted. However, there is no special reduced data requirement for intermediates. Annual Reporting of Notified Substances Below is a link to 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

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annual report on line by 1 February each year. You need no longer submit the paper report. Please also find attached the manual for the online submission. http://www.mepscc.cn/tabid/75/InfoID/1058/frtid/40/Default.aspx

JAPAN

On 1st April 2016, METI announced the addition of 21 new substances to the list of priority substances (PACS) which will undergo further risk assessment in future. The list of substances can be found via the following URL (Japanese only). The first/top pdf link after the announcement gives the PACS number and chemical names of the 21 substances newly added. The second pdf link provides details of all the PACS substances designated to date, including METI codes applicable to those substances. http://www.meti.go.jp/policy/chemical_management/kasinhou/information/ra_16040101.html For the newly designated substances, the enhanced information requirements for reporting PACS will commence with the June 2017 annual volume reporting exercise for the fiscal year commencing 01/04/2016. METI have recently published software tools, including installation and operating manuals, to assist industry with the GHS classification and labelling of mixtures and to promote the wider adoption of GHS for mixtures in Japan. This is based on the 4th revised edition of UN Purple book and is consistent with the Japanese GHS standard JIS Z 7252:2014. The information is provided in the following link (in English).

http://www.meti.go.jp/policy/chemical_management/int/ghs_auto_classification_tool_ver4_EG.html On 15 December 2015, Japan’s Ministries of Health, Labor, and Welfare (MHLW), of Economy, Trade, and Industry (METI) and of Environment (MoE) jointly announced that they are seeking public comment on their proposal to designate two substances, polychlorinated naphthalenes and pentachlorophenol and its salts and esters, as Class I Specified Chemical Substances based on the Chemical Substances Control Law (CSCL). Japan Nominates 27 Substances Subject to Mandatory Labeling, SDS and Risk Assessment under ISHL. MHLW selects 27 substances for SDSs and labelling. 17 December 2015 / Japan, Classification, labelling & SDS.

SOUTH KOREA

A comprehensive review of the current situation under K-REACH was provided in the 2015 annual report. During Q1 the following issues have emerged:

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Launch of a Central Environmental Crime Investigation Task Force On February 17, 2016 the Ministry of Environment (MoE) introduced the Central Environmental Crime Investigation Task Force in an effort to strengthen its ability to better enforce against major environmental violations. In a press release, the MoE announced that it expects to strengthen its on-site enforcement capability, with the Task Force serving as an overall supervisor for environmental crime investigations. Further, to allow for the effective development of K-REACH and the Chemicals Control Act, the authorities are expected to strengthen its enforcement strategies. To this end, it is possible for the new Task Force to oversee the investigation planning and enforcement of the relevant regulations. Given these developments, Cefic member companies may wish to ensure that their local entities are compliant with Korean environmental laws and regulations. Data Protection On March 18, 2016, MoE held an information session on the reasons and supporting evidence for data protection for the benefit of companies that have submitted a chemical substance data protection application. Specifically, the session was held to provide guidance on the documents and supporting evidence needed to substantiate a data protection claim against the MoE’s disclosure of data submitted as part of the Statistical Survey and Emissions Survey. At the session, the MoE requested that companies submit specific reasons and evidence supporting each point for which non-disclosure is claimed by the May 31, 2016 deadline. Below is a summary of the key points discussed at the information session.

- “Trade secrecy” (i.e. confidential nature) of the chemical data must be clearly described with reasons and supporting evidence for each item for which protection is requested.

- Economic value should be substantiated with specific data, showing the economic advantage, cost-saving effect, effect on market share, etc.

- If data protection is claimed for the product name or chemical name, an alternative name should be provided.

- Persuasive reasons must be presented for a claim to protect the amount in circulation data (e.g., stocked and released volumes) to be granted. A key take away from the information session appears to be that the MoE will require an analysis of the application and effect of the substance, as well as its market impact, together with reasons and evidence supporting the analysis in order to complete the data protection claim. Industrial Safety and Health Act The Korea Ministry of Employment & Labor has revised the regulations under Industrial Safety and Health Act (Occupational Safety & Health Act). A summary of the revisions and relevant attachments are available on request. Guidance & Publications An MOE Summary Guidance on Reporting by Overseas Manufacturers and Producers is available on request.

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An English language document on K-REACH compliance, are also available on request. Annual Reporting The submission of the first annual report started on Jan 1st of 2016 and will end on 30 Jun 2016. New chemical substances regardless of volume and existing chemical substances imported or manufactured in volumes of 1 ton or more in the previous year (Jan 1-Dec 31) require reporting. The report should be submitted through the IT system which is in Korean for the moment, but an English interface will soon be available for the reporting part only. The foreign manufacturer can request the importer to provide the log-in ID in order to submit directly information that is designated CBI. The information in the report has to be prepared following the Guidance on Reporting by Overseas Manufacturer or Producer (issues on 26 February 2016). An English summary of this guidance was published by MoE. Lead Registrant elections for the Priority Existing Chemicals By the end of March 2016, Lead Registrants were elected for 196 Priority Existing Substances, and the results were made public. There were still 341 substances requiring a Lead Registrant and MoE urged potential registrant to join as soon as possible the Chemical Substance Information Communicative Organization (similar to EU SIEF).

TAIWAN Existing chemicals Pre-registration ended 31st of March 2016 The pre-registration of existing chemical substances ended the 31st of March 2016. The companies that were not able to pre-register within the prescribed deadline need to voluntarily notify the authority of uncompleted pre-registration with a formal statement (by post). According to the Article 19 of the revised Taiwan Chemical Substance Control Act (TCSCA), a late pre-registration can be submitted for existing substances imported or manufactured in quantities above 0.1 t/y, starting with April 1 2016. The late pre-registration should be submitted within 90 days after the first manufacture or import, through the on-line system. Information requirements for pre-registration include the following sections: registrant identification, substance identification, substance manufacture and use information, supporting evidence for the first manufacture/ import. Required supporting evidence includes: substance identification, proof of first manufacturing/ import (declaration for import, trade receipt, sales contract or shipment certificate from the manufacturer).

Initiation of Custom Supervision and Inspection Section System Taiwan customs initiated the supervision and inspection of imported chemical substances, by launching a platform for chemical commodity import pre-confirmation. Imported products which contain chemicals subject to registration under TCSCA shall be pre-confirmed through this platform. In case of chemicals contained in products and subject to registration obligations, the pre-confirmation is needed only for the first import. Currently the pre-confirmation is not mandatory. The platform is managed by EPA and local

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environmental protection departments to support a better implementation of the chemical registration scheme. The information collected via this platform will serve as basis for post-market inspection.

Use of OR model instead of TPR A major issue for the foreign manufacturers is the Third Party Representative (TPR) system currently used in Taiwan. The TPR only works for domestic importers or manufacturers. For the foreign manufacturers the TPR concept is a major challenge. Following the discussions that Cefic GER conducted with EPA and SANTECH, the Taiwanese authorities consider using the OR model instead of TPR. However, no amendment is currently drafted but according to a local source, inter-ministerial discussions are already conducted.

INDONESIA Regulation number 74 Year 2001 Ministry of Environmental has issued latest Draft of Government Regulation regarding Hazardous and Toxic Substances Management. This regulation soon will replace regulation number 74 Year 2001. The draft is still under discussion and consultation among Ministries. Chemical Industry is represented by Ministry of Industry. Some concern has been raised to the Ministry of Industry regarding the draft. Concern included cut off value for mixture products, limited use substances that required notification not in line with International Convention on Prior Informed Consent (Rotterdam) and classification reference. As this is new we do not have further details yet. Chemical Act No update as yet related the Chemical Act. This year the Chemical Act is not listed as a regulation to be legalized. The Ministry of Industry is still the focal point for this. Ministry of Man Power Regulation No. 187/MEN/1999 Concerning the Control of Hazardous Chemical Substances in the Workplace. The Ministry of Man Power is working to prepare draft of new regulation to replace Regulation No. 187/MEN/1999 Concerning the Control of Hazardous Chemical Substances in the Workplace. In the draft, requirements for SDS are referred to the GHS regulation.

MALAYSIA

The Department of Environment held a consultation with the industry on the first public draft of the Environmentally Hazardous Substance Regulation in December 2015. Industry has been expecting DOE to formalise the voluntary Environmentally Hazardous Substance

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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 Environmentally Hazardous Substances (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 EHS 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. However, several issues were noted including the wide scope of who has to notify (as is currently written, would include manufacturers, transporters, users, etc), and lack of details on the risk assessment (scope, purpose, etc). It is considered that the 2 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 EHS. Unfortunately at this time industry is not able to share the draft regulation outside of CICM but some member companies may have seen scanned copies from their Malaysian colleagues.

THAILAND Headline: As reported throughout 2015 Thailand is to revise its Chemicals and Hazardous Substances Management scheme to include the establishment of an Existing Chemicals Inventory. Although precise details are awaited, the Cefic membership is alerted to the fact that an inventory nomination phase during the year could be established in order to define chemicals as existing. As reported in the 2015 annual report The Department of Industrial Works (DIW) have 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 been rumored that a preliminary inventory might be published within the first quarter of 2016. 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 is December 31, 2016. During recent informal discussions with DIW representatives they suggested that there is no intention to establish a conventional new chemical notification scheme but that they are seeking to understand better those chemicals are in Thailand (the national inventory is seen as a critical first step for the authorities to know this) and after an “evaluation,” in the form of a risk assessment, that DIW will determine which chemicals that need to be additionally added to the list of controlled chemicals that currently exists. As for CBI, DIW has a notification procedure envisaged i.e. the 3rd party reporting process, but there will be the need to further industry to explain various other aspects of CBI , for

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example where the very existence of the chemical is confidential. DIW representatives expressed a willingness to learn more about industry’s concerns. GER will form a Thailand sub-group to address these issues and prepare an advocacy plan. Developments will be reported in due course.

AUSTRALIA

Inventory multi-tiered assessment and prioritisation (IMAP) programme IMAP Tranche 17 reports will be published during the week beginning 18 April 2016. Interested parties will be able to comment on these assessment outcomes. Consultation will close eight weeks after publication. NICNAS reforms consultation The public submission on NICNAS reforms consultation paper 1 are available online now; https://www.nicnas.gov.au/communications/consultations/past-consultations/nicnas-reforms/public-submissions-on-nicnas-reforms-consultation-paper-1 Consultation Paper 2; Implementing reforms to the National Industrial Chemicals Notification and Assessment Scheme was released by NICNAS in February 2016, with an invitation to industry to send comments before 30th March 2016. Consultation Paper 3 will be released in May 2016.

NEW ZEALAND

There have been no further notices released by the EPA in this quarter though they still have plans to issue notices on Enforcement Officer qualifications and hazardous classification system, labelling, safety data sheets, and packaging. Specifically on the consultation document, ‘Reforms of Hazardous Substances Management under the HSNO Act – Proposals for EPA Notices for Classification, Labelling, SDS and Packaging’ which closed for comment in February 2015, the EPA advise they are still considering the submissions made.

SWITZERLAND

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 2018.

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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 it’s, Classification and Labeling, intended uses, and if considered dangerous, and the tonnage band (<1 / 1-10 / 10-100 />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 as well.

US

Companies are preparing for their entries into the Chemical Data Reporting (CDR) tools for the reporting cycle due mid-2016. Discussions are still underway in the US Congress to agree on language for specific portions of the TSCA draft bills, to allow for one revised document to be presented later this year to the President for signature. Provisions in the bill will be implemented by the government and put into place by industry over the next 3-5 years after coming into law.