Product Stewardship - Regulatory Summit Europe 2019

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Title	Evaluation	Comments
Regulatory Trends Sylvie LEMOINE
SCIP database of articles containing substances of very high concern Kevin POLLARD, Head of unit, Exposure and Supply Chain Unit
REACH Challenging decisions on subsance evaluation Claudio MEREU Joint Managing Partner Fieldfisher (Belgium) LLP	***	Reviews of BoA and EU Court of justice cases and the justifications of decisions. In particular, cases are related to EORGP, QSAR, Weight of evidence,..
Recent Trends on REACH Authorisation, SVHCs and Restrictions Jean-Philippe MONTFORT
Reach Evaluation Action Plan Cristina DE AVILA, Head of Unit DG Environment, European Commission	***	REFIT process lead to actions: Promote substitution, simplication of the process and interpaly between autorisation and restriction. Review of challenges of SVHC process (impuriy, UVCB, ED, PMT,..) Restriction: How to demonstrate "unacceptable risk" => What about proportionality of Risk eg: EU court consider that if Effects are “possible". Authorisation has to be considered.
Update on ECHA activities concerning annex VIII to CLP _ poison centre notifications Heidi RASIKARI, European Chemicals Agency		Notification file by 1st Jnuary 2020/2021/2024 UFI on Labels by 2025 Use the-ncec.com/poisoncentres
Ingredient Disclosure in the United States Steve CALDEIRA, President & CEO
TSCA overview and new chemicals update Rose PASSARELLA, Ph.D., J.D., Senior Manager, Regulartory	****	PMN process SNURS requirements for new uses and communication in the supply chain CBI: 3 new rules/Changes: on chemical indentity, Public availability of submission, Timeline of CBI request NOC: Notice of commencement Chemical Data Reporting (CDR) rule
Industry perspective on working with US TSCA Adriana JALBA, ICL Group
The NGO Response to U.S. EPA's Implementation of the New TSCA Herb ESTREICHER, J.D., PhD, Partner	*	List of NGO 's engaged with TSCA Petition to expand TSCA reporting requirements for asbestos. NGO Petitions to Try Force EPA Take Action: Fluoride Chemicals in Drinking water, TetrabromobisphenolA (Flame retardant), Chlorinated Phosphate Ester Cluster (Flame retardant), Use of Hydrofluoric Acid (HF) at Oil Refineries
Threats to implementation of 2016 TSCA reforms, and intersections with REACH Richard A. DENISON, PH.D., Lead Senior Scientist	***	List of improvements of TSCA but also critical review of TSCA and EPA substances risk assessment in comparison with REACH:
Updates on Chemicals Management in Canada Mary Ellen PERKIN, Manager, Cusumer and Cleaning Products, Products division	***	Good review of Canadian regulatory obligations Before importing or manufacturing the substance, the Government of Canada must be notified. For existing substances, The Government of Canada committed to address 4300 substances by 2020 and to manage risks. The process of risk assessments performed by Canadian authorities are indicated in the slides. Published Published Published Published Published Published Published risk assessment reports for 3842 of 4300 priority risk assessment reports for 3842 of 4300 priority risk assessment reports for 3842 of 4300 priority risk assessment reports for 3842 of 4300 priority risk assessment reports for 3842 of 4300 priority risk assessment reports for 3842 of 4300 priority risk assessment reports for 3842 of 4300 priority risk assessment reports for 3842 of 4300 priority risk assessment reports for 3842 of 4300 priority risk assessment reports for 3842 of 4300 priority risk assessment reports for 3842 of 4300 priority risk assessment reports for 3842 of 4300 priority risk assessment reports for 3842 of 4300 priority substances identified during categorization
California Proposition 65 Update Michael Easter
Regulatory Update on Chemicals Management in China Heng LI	****	-Review of the Revision to the MEP Order No.7 Explanation of Post-registration requirements and in particular a newly introduced concept “New use management” Use(s) other than the permitted use(s) ( listed in IECSC) are subject to a new approval by the MEE - Update on the management of existing substances Focus on prioritised existing substances Art15 reporting? (Submit data + tests)
Chemical Regulations in Japan Veszprem-SZABADSAGPUSZTA & David J ESDAILE		- Overview of Chemical Substances Control Law (CSCL): Notification and evaluation processes. Amendment to CSCL: Exemption for small and low volume of new chemicals & Specified general chemical substance rule newly introduced for polymer - Overview of ISHL Substances subject to the SDS delivery, labelling and the risk assessment has been increased on 1 July 2018 Amendments of JIS Z 7252: Classification of chemicals based on GHS and JIS Z 7253: Hazard communication of chemicals based on GHS-Labelling and SDS
Updates on South Korea_ K-REACH and K-BPR Olivier Weiss, KIST Europe, Germany	***	Overview of K-REACH 1.0: Designation of PEC substances and K-REACH 2.0: Transition to a tonnage based systems Discussion on polymer exemption from registration :Proof of exemption from the Article 11 Enforcement Decree
Australia's Chemical Framework_ Overview & Updates Nhat NGUYEN, Chief analyst, Chemicaln Watch	**	- Update -SUSMP No. 24 (Poisons Standard October 2019), Update - Therapeutic Goods (Permissible Ingredients) (September 2019), Update - Australian regulatory guidelines for sunscreens (ARGS)(August 2019) - GHS & Occupational Hygiene: Authorities are looking into adopting the 7th ed - NICNAS Reforms: New Process of notification (introduction of risk assessment) : Effective date July 2020 Description of New obligations under AICIS : what is Exempted, Reported, Assessed. Mutual recognition: Recognized Canada and REACH EU’s assessment. Chemicals assessed underTSCA would be accepted only in a internationally parallel process
ASEAN developments including Thailand and the Philippines Dr Gunnar KAHL and Dr Piyatida PUKCLAI	**	How to determine hazard type under DIW Obligation of Chemical inventory under the new Chemical Act (List 1,2 and 3) Enforcement? Philippine Inventory of Chemicals and Chemical Substances (PICCS): Pre-Manufacturing and Pre-Importation Notification (PMPIN ) Overview on Malaysie and Vietnam
Chemical Substances Registration in Taiwan Dr Yi-Kuen LIU, Ph.D., Director of Comprehensive planning Division, toxic chemical Substance Bureau (TCSB), EPA, Taïwan	**	Overview of Taiwan regulations
South America_Chemical Regulations Recent Developments	***	Recent Developments of Chemical Control Regulations in Argentina, Brazil, Colombia and Chile
Eurasia REACH_Shedding light on common misconceptions Olesia POCHAPSKA, Senior Manager		Clarification of some misunderstandings related to Eurasian REACH
Africa demography, development and chemicals management V. GARNY		Kenya 2018 Draft IndustrialChemicals South Africa2018 Draft Regulationfor HazardousChemical Agents (GHS) and some aspects of chemicals management (on hold)
Turkish REACH-like Regulation KKDIK Dr Yaprak YUZAK KUCUKVAR, Manager RGS Turkey		Time for KKDIK Pre-registrations Transfer of REACH experience and the use of REACH data for registrations in Turkey
India_ Chemical Regulations and Management Dr Rajesh RAMAMURTHY, Vice president & Regional Head Product Stewardship Asia		Overview of Current Chemicals Legislative Framework in India Trade Regulations of chemicals Insecticide regulation Manufacture Storage & Import of Hazardous Chemicals Transportation of Chemicals Protection of human health and environment

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