Global Emerging Regulations (GER) Issue Team Quarter 3 Report

Transcription

1 Global Emerging Regulations (GER) Issue Team 2016 Quarter 3 Report September2016

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3 This report covers those non-eu countries where regulatory reform has occurred or continued during Quarter 2, Those Cefic Members who only wish to refer to selected regions may click on the list in the table of contents for immediate access. The previous reports issued were the annual publication for 2015 and the quarter 1 & 2 updates, which are available on request. In case members would like to have information on other countries, Cefic should be contacted for information (Erwin Annys, ean@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 JAPAN 3 TAIWAN 4 INDONESIA 4 THAILAND 4 EURASIAN ECONOMIC UNION (EAEU) 5 US 5 BRAZIL 5 MEXICO 6 COLOMBIA 6 2

5 MAINLAND CHINA (People s Republic) In the Quarter 2 report Cefic members were alerted to the fact that the China Inventory (IECSC) may re-open for the supplementary submission of substances that were manufactured, imported or used in China before 15 th October Although this is still under consideration, there is no new information regarding the opening of IECSC. Three issues have emerged since June: Risk Assessment of Existing Chemicals China's MEP's Solid Waste and Chemical Management Center (MEP-SCC) has issued a draft technical guidance for the health and environmental risk assessment of existing chemical substances. The government will conduct the assessment work as there is no regulation to support the registration of existing substances. The plan sets a deadline of 2017 for the government to publish a list of Priority Existing Chemicals subject to control. Inventory of Hazardous Waste This became effective in August 2016 and significantly expands the scope to include the China Inventory of Hazardous Chemicals (2015). There has also been an amendment in terms of scope and exemption on medical wastes. Six national standards are available for test methods to determine hazardous wastes. Order 40: Worker Safety Order 40, which became effective in July 2016, requires manufacturers and importers of the priority substances identified, to register under the current scope of Order 53 to the SAWS (State Authority for Worker Safety). Finally, the new guidance document for Order No.7 in China will be delayed due to some important changes that need to be made to the draft submitted to WTO. The publication of the guidance was expected in October, after the WTO review. JAPAN The situation with regards to the list of priority substances (PACS) remains as previously reported. For Small Quantity Notifications (1MT/annum) to METI, submissions between 1 st and 9 th September will allow manufacture or import to commence from 1 st October. The next opportunity is between 1 st and 9 th December for substances manufactured or imported as from 1 st January

6 TAIWAN Phase I Registration Following Phase I of Taiwan s existing chemical registration (pre-registration), around 450 chemicals will be designated into 3 separate lists (i.e. based on perceived hazard). The first list of around 100 substances is expected to be published during Third Party Representative (TPR) So far, there is no intention of the authorities to align the Taiwanese TPR with the EU OR. Such a change will require an amendment to the current law. Discussions around this issue remain a priority for the GER group. INDONESIA There have been no developments with regards to the chemical act. In late 2014, the Indonesian Parliament passed the Halal Law, which implies all products in its scope have to be Halal certified or labelled non-halal. Subsequently the Ministry of Religious Affairs has issued a draft implementing regulation in June The law has a wide scope and it appears the Authorities wish to extend it even further than just food and beverages, but it is also unclear how far up the supply chain the requirements will extend. It was hoped that the June draft implementation regulation would provide more clarity, but it only explains the process on how to obtain certification, not the scope. The draft implementing regulation states that further regulations will be released to list the actual products in scope. It appears however that the Ministry of Health is opposed to drugs and pharmaceuticals being included. The situation will be closely monitored. THAILAND The draft inventory is now available on-line and links are being established. To ensure an inventory listing it will be necessary to file a List 5.6 notification to DIW and the cut-off date for notification to ensure a substance is defined as existing is reported to be December 31, The most difficult question to answer at the moment is whether the registration process is for all chemicals or just for those associated with a hazard. It was mentioned that when submitting a registration, one of the fields is an indication of the hazard. The decision to notify or not is important as on one hand there could be commercial and financial implications for not obtaining existing substance status for their chemicals, whilst on the other hand there is a risk that non-hazardous chemicals could be perceived as hazardous. 4

7 It is also unclear on how a non-hazardous preparation which contains a hazardous ingredient is treated. Urgent work will be undertaken to address the concerns and questions. EURASIAN ECONOMIC UNION (EAEU) Russia, Kazakhstan, Belarus, Armenia, Kyrgyzstan Development of the Technical Regulation As previously reported, the EAEU intends to finalize and publish the Technical Regulation before the end of Preliminary information indicates that registration requirements are onerous (no de minimis threshold foreseen for Registration requirement and heavy data requirements on new substances). There is no public consultation open, therefore no mechanism to provide feedback to the authorities at this point in time. Timings The Technical Regulation is expected to be published before the end of 2016; Completion of Inventory of existing substances and mixtures by December 1, 2017; Implementation of legislation expected by December 2, It is recommended that Cefic Members register all their substances on the current Russian inventory (via the Russian registration procedure, similar to the poison centers in EU), before end Indeed the current inventory only contains ~10,000 existing substances. As there is no possibility to comment on the existing draft, the focus is now on the second tier legislation which will provide all the technical details, with the goal to engage the authorities and try to have a collaborative approach. GER seeks also opportunities to collaborate with Petroleum Chemical Association, Chemical Industry Association as well as key trade partners of the EAEU countries, to raise awareness in order to support Cefic s advocacy effort. US TSCA Reform H.R The final negotiated bill to reform the Toxic Substances Control Act (TSCA) has now been signed into law. EPA is currently preparing guidance documents and developing timelines. The situation continues to be monitored and progress will continue to be reported. BRAZIL Public consultation on Draft Regulation of Industrial Chemical Substances As reported in Q2, on June 30 th, draft legislation (Regulação de Substâncias Químicas Industriais) was released for a 45 day commenting period. This deadline has been extended to the end September. The GER team has prepared comments on general principles of the 5

8 draft law, as well as on the content of each article. The comments will be submitted in due course with local help from a member of Cefic. The intention of the draft is to create a national inventory of the chemical substances on the Brazilian market, and then to prioritize the substances to be assessed (PBT, CMRs, endocrine disruptors, substances that may be relevant due to the exposure and substances subject to international conventions). No technical details are provided in this first draft, but subsequent implementing regulations are expected. MEXICO Chemical Policy: Canada, the US and Mexico have formed an independent North American Commission for Environmental Cooperation. With regards to this, Mexico is committed to follow the Strategic Approach to International Chemicals Management (SAICM) as a policy framework to foster the sound management of chemicals. In May 2016, Secretariat of Environment and Natural Resources (SEMARNAT) and National Institute of Ecology announced the need of implementing National Chemicals Inventory in Mexico. It is understood that by 2020 a chemical inventory will be mandatory and compliance to it will be relevant for both importers and local manufactures. ANIQ (National Association of Chemical Industry) has mentioned that publication of the inventory may be accelerated to It is rumored that besides the traditional type of information required for inventory reporting, information on uses and details of impurities are being considered. COLOMBIA Colombia is contemplating the regulation of hazardous chemicals. No details are available for the time being. Further developments will be monitored and reported. 6