2017 Chemical Watch Expo 2017 UL-SCS/WERCS

Transcription

1 2017 Chemical Watch Expo 2017 UL-SCS/WERCS REACH s consequences An overview of how REACH is spreading globally Presented by: Christine Lepisto Regulatory Expert 2017 Underwriters Laboratories Inc.

2 Agenda 1. Roots of REACH 2. REACH in the rest of Europe 3. REACH Reaction: example China 4. REACH Evolution: example South Korea 5. REACH Additional obligations: example USA 6. QA 2

3 Roots of REACH A look at the new model of chemical control that will spread

4 Country Year Legislation Before REACH: Chemical Control Laws European Union 1967 European Inventory of Existing Commercial chemical Substances/ European List of Notified Chemical Substances/ No-longer Polymers (EINECS/ELINCS/NLP) Japan 1973 Existing and New Chemical Substances (ENCS) USA 1976 Toxic Substances Control Act Section 8(b) Inventory (TSCA) Australia 1989 Australian Inventory of Chemical Substances (AICS) Philippines 1990 Philippine Inventory of Chemicals and Chemical Substances (PICCS) Canada 1990 Domestic and Non-Domestic Substances Lists (DSL/NDSL) Korea 1991 Korean Existing and Evaluated Chemical Substances List (KECL) New Zealand 2006 New Zealand Inventory of Chemicals (NZIoC) Turkey 2008 Regulation on Inventory and Control of Chemicals Mexico 2009 National Inventory of Chemical Substances (INSQ) Malaysia 2009 Environmentally Hazardous Substance Notification and Registration (EHSNR) China 2009 Inventory of Existing Chemical Substances in China (IECSC) Taiwan 2014 Taiwan Chemical Substance Inventory (TCSI)

5 Chemical Control Laws: a flawed model Existing Chemicals All chemicals in commerce nominated Assumed safe Burden of proof on the authorities New Chemicals Registration costs a disincentive to R&D Fun fact: Over 100,000 substances listed in the EU when REACH was adopted! 5

6 REACH Registration proceeds in Europe Preregistration Total Dossiers 2010: : : ? >1000 t/y CMR; N 3675 substances >100 t/y = 6673 >1 t/y = 12.5K 12.5K? Non-phase-in Substances (not in EINECS/ELINCS) 1 June Dec Dec May 2013 Mid May 2018 Sources:

7 REACH Registration costs Tier ECHA Fee Registration costs >1000 T/y 25, T/y 9376 % T/y T/y 1304 Thousand Fees and data make half the costs In-house staff costs <25% for >75% of firms surveyed Consulting costs <25% for >75% of firms surveyed Average cost K Lead registrant Simple registrant Sources: Source: CSES-REACH-COST-andOtherCaseStudies_market-annex_en Interim Evaluation: Functioning of the European chemical market after the introduction of REACH, Final report, 30 Mar

8 What makes REACH REACH? No existing chemicals No safe assumptions, all treated like new chemicals Data sharing Required to minimize animal suffering No Free Rides It s not an inventory, it s a buy-in to the ownership of data proving chemical safety Prove safe use burden on industry Exposure scenarios workers, public, and environment New substance: a liquid with holes in it 8

9 First wave of expansion: REACH in Europe Outside the European Union

10 Non-EU Members: REACH reciprocity or parallel system European Free Trade Association (EFTA) Countries European countries not in the European Union reduce trade barriers and ensure equivalent protections Norway, Iceland, Lichtenstein, and Switzerland Norway, Iceland, Lichtenstein are part of REACH through the European Economic Area (EEA) multi-lateral agreements Switzerland enforces the provisions of REACH via national regulation (ChemV) Britain post-brexit??? 10

11 Turkey REACH and real Turkey REACH Turkey REACH Regulation on the Inventory and Control of Chemicals (CICR) Two tonnage bands and >1000 T/y Notification of data in possession of notifier Real Turkey REACH KKDIK Regulation: KKDIK is the acronym for REACH in Turkish As an EU accession candidate, Turkey implements national regulations equivalent to EU regulations 11

12 REACH Reaction China MEP Order 7

13 China MEP Order 7 Inventory of Existing Chemical Substances (IECSC) This regulation is similar to EU REACH and is also known as China REACH Source: the internet, so it must be true (???) Fun fact: This tiger is not grimacing about REACH or MEP 7. Stinking face is an instinctive response that opens the vomeronasal, or Jacobson's Organ, for better identification of chemical odors Image (and fun fact) Credit: Rob Bixby, CC-by-2.0 Sources:

14 China REACH MEP Order 7 Measures for the Environmental Management of New Chemical Substances 100 kg/y 1 t/y 10 t/y Regular new substance Simplified notification general conditions Regular notification Isolated Intermediate Product and Process R&D Polymer of Low Concern Scientific Research or Testing Simplified notification special conditions Simplified notification special conditions (valid 2 yr) Simplified research record Simplified notification special conditions (No volume limit) Simplified notification Regular notification Regular notification Regular notification 14

15 China REACH Confidentiality measures EU Manufacturer Non-Chinese supplier Chinese agent Importer 1 Flow of goods Flow of information Certificate issued Importer 2 15

16 China MEP Order 7 vs. EU REACH Existing Chemicals EU REACH: applies to ALL chemicals >1 T/y/entity China REACH: Applies only to NEW chemicals Not required for >45,000 substances listed on IECSC New substances >=1 T/y full registration No de minimus threshold for some notifications and R&D notification is limited to 0.1 T/y (100 Kg) 16

17 China MEP Order 7 vs. EU REACH Data sharing EU REACH: Tiered dossier by tonnage band; data sharing mandatory. Industry SIEF mechanism to determine how to share costs China REACH: Tiered dossier by tonnage band; no requirement for data sharing Subsequent notifier can use the dossier submitted by notifier-1 with notifier-1 s permission but must comply with the testing for the sum of notifier-1 + notifier-2 s manufacturing/import tonnage Joint notifiers also must submit data relative for the combined tonnage 17

18 China MEP Order 7 Data sharing example Notifiers A and B have no connection in this example but the data level for notification must comply to the sum of all notifiers tonnage Substance X Data for regular notification level 1 Purchase access rights Notifier A Notifier B Regular notification 8 t/y OK NO Regular notification 5 t/y Only 2 t/y can be permitted based on data available 18

19 China MEP Order 7 vs. EU REACH No free rides? EU REACH: Joint or individual registration allowed, but all companies marketing the substance over the threshold quantity must register China REACH: IECSC is not static! After a substance is added to the China Inventory, there seems to be no requirement of China REACH to further register the substance Company A Regular notification 10 t/y OK After 5 years, substance listed on IECSC Company B Free rider, unlimited tonnage 19

20 China MEP Order 7 vs. EU REACH Proof of safe use EU REACH: Chemical safety assessment if >10 T/y China REACH: Risk assessment starting at > 1 T/y; RA must follow Chinese guideline cannot reuse EU CSR Communication in supply chain to ensure safe use EU REACH: Extended SDS and other support to downstream user, who is responsible to ensure their own safe use China REACH: obligation not to sell to downstream users that are not capable of implementing the Risk Management Measures (RMMs) for safe use 20

21 China MEP Order 7 other differences Polymers EU REACH: Notify monomers China REACH: Notify all new polymers (simplified if new monomers <2% and polymer of low concern ) Submittal rights EU REACH: only an EU-based natural or legal person can register; no specific OR requirements China REACH: Foreign entity can submit directly to MEP or through their subsidiary or through an Only Representative (OR); Local agent can submit through an OR; OR must meet minimum requirements (capital, fixed work place, experience, no violations in last 3 years) Lab requirements EU GLP versus China: Ecotox tests in Chinese laboratories 21

22 Other Reactions Reaction drivers Responsible chemical management policies advocated by United Nations Trade protection motivator Reaction characteristics More emphasis on generating data for existing chemicals Duties to provide information to governments and users Reaction spreading Malaysia Taiwan Thailand 22

23 REACH Evolution Korea REACH (a.k.a. K-REACH) and!!!new!!! MoE

24 Korea REACH a.k.a K-REACH Act on Registration and Evaluation of Chemical Substances, etc. Image source: Ministry announcement ( 24

25 K-REACH vs. EU REACH Existing Chemicals EU REACH: applies to ALL chemicals >1 T/y/entity K-REACH: dual reporting/registration scheme covers all new and existing chemicals Reporting: the first level of obligation is to report the use of the new chemical or at least 1 T/y of the existing chemical Registration: applies for new chemicals but only applies to existing chemicals designated as subject to registration existing chemicals may be designated at quantities < 1 T/y 25

26 K-REACH vs. EU REACH Data sharing EU REACH: Tiered dossier by tonnage band; data sharing mandatory. Industry SIEF mechanism to determine how to share costs K-REACH: Tiered dossier by tonnage band CICO: Chemical Information Communication Organization = SIEF under KCMA (Korea Chemicals Management Association) but transitioning to KECO (Korea Environment Corporation) Data acquisition support by KECO and NIER (Natl. Institute of Environmental Research) 26

27 K-REACH vs. EU REACH No free rides? EU REACH: Joint or individual registration allowed, but all companies marketing the substance over the threshold quantity must register K-REACH: For a substance on the Korean Existing Chemicals List, the Ministry of Environment may designate that registration is required. Other existing chemicals are subject to annual reporting, but not registration 27

28 K-REACH vs. EU REACH Proof of safe use EU REACH: Chemical safety assessment if >10 T/y K-REACH: Submittal of risk data in addition to hazard data starts at > 100 T/y (stepping down to 10T/y in 2020); Ministry must make a risk assessment Communication in supply chain to ensure safe use EU REACH: Extended SDS and other support to downstream user, who is responsible to ensure their own safe use K-REACH: Two-way communication requirement in supply chain is modelled on REACH 28

29 K-REACH vs. EU REACH Polymers EU REACH: Notify monomers K-REACH: Notify all new polymers Exemptions EU REACH: User determines that their case is exempt K-REACH: confirmation of registration exemption required for cases like R&D, nonisolated intermediates, export-only goods Reporting EU: none required under REACH K-REACH: requires annual report of uses, quantity and other matters defined by ordinance 29

30 Korea Ministry of Environment Announcement Key proposed amendments to K-REACH Objective: reduce the focus on prioritized lists (toxic / authorized / restricted / prohibited) and exert hazard-based controls prioritizing hazards such as CMR, PBT, and endocrine disruptors Article 8: abolish reporting, introduce chemical pre-registration Article 9: 3-phase registration system of existing substances abolished Article 10: registration for ~7000 existing substances ( 1t/y) will apply Article 25: improve management system of approved substances Article 29: Expand information communication requirements Article 32: notification of chemicals contained in products 30

31 Korea Ministry of Environment Announcement Milestone Anticipated timeline Comments Feedback Closed Feb 2017 Guidance Project started with DRAFT anticipated late 2017 and final guidance in 2018 Final K-REACH Amendment June 2017 Pre-registration Beginning late 2017 Enforcement date of K-REACH amendment June 2018 (1 year after amendment enacted) Expected tonnage band schedule*: >= 1000 t/y: July 2018 June t/y: July 2021 June t/y: July 2024 June t/y: July 2027 June 2030 *NOTE: Due date for Phase 1 PECs remains unchanged: June 2018! 31

32 Korea Ministry of Environment Announcement Obligation Current K-REACH Amended K-REACH (anticipated) Reporting New and existing substances >= 1t/y Abolished (NOTE: CCA reporting) Pre-registration Not applicable Existing substances >= 1t/y Registration Substance notification Product notification All new chemical substances PECs >= 1 t/y Contain hazardous substances >= 1 t/y All new chemical substances >= 0.1 t/y Existing substances >= 1t/y (by tonnage band deadlines) 510 PECs deadline June 2018 New chemical substances <0.1 t/y Contain hazardous substances >= 1 t/y Exemptions KCMA evaluation KECO takes over from KCMA Risk management Communicate hazardous substance Manage risk-concern product Risk assessment by tonnage bands Communicate risk-concern substance Manage risk-concern product* Risk assessment same timeline *NOTE: Safety Control Act of Household Chemical Products and Biocidal Products 32

33 K-REACH: where are we at now? 510 Priority existing chemicals (PEC) First successful joint registration (HBr, CAS ) has recently been issued a registration number by MOE/NIER Original deadline for K-REACH registration of 30 Jun 2018 will still apply. Companies concerned by this notice should focus first on any of these 510 PEC substances, ensuring that they have a process in place to work with the industry joint registration group to ensure their continued marketing of the products containing such substances remains legal in Korea Annual reporting Continues at least for 2017 reporting (30 June deadline) 33

34 Additional obligations from REACH Don t overlook the consequences of new information

35 REACH Global Data Flows In-house Database IUCLID Bulk XML REACH-IT C&L Notification Registration Company files China NCSN K-REACH USA TSCA Free Software Commercial Software 35

36 Additional information example: USA TSCA TSCA Section 8(e) (e) Notice to Administrator of substantial risks Any person who manufactures, processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the Administrator of such information unless such person has actual knowledge that the Administrator has been adequately informed of such information. Immediately = within 30 days Source: 36

37 Additional information example: USA TSCA CEFIC memorandum on TSCA Section 8(e) This requirement applies to entities in the U.S. (including importers), not to exporters from the EU to the U.S. However, in some cases where EU entities have knowledge of such information, their U.S. affiliates may have that knowledge also. In addition, in some cases EPA may infer that the U.S. affiliate has that knowledge, particularly where the U.S. entity is the parent of the EU affiliate. In those cases, EPA may consider that the U.S. affiliate is required to submit such information to EPA. Source: obligations%20and%20tsca%20%c2%a7%208%20(e)_ pdf 37

38 Additional information example: USA TSCA TSCA Section 8(e) FAQ Any information, including preliminary information, from human health and safety studies and animal studies on a chemical in commerce that implicates the tested chemical causes toxic effects when there is also an exposure concern should be reported to EPA under TSCA 8(e). The decision to report should not hinge in any way on a judgment about the relevance of the findings to an assessment of human risk. For the most serious toxic effects (e.g., cancer, neurotoxicity, birth defects), the decision to report should not even depend on a judgment of actual or potential exposure to the chemical. The mere fact that the chemical is in commerce constitutes sufficient evidence of exposure. Source: Toxic Substances Control Act Section 8(e): Frequent Questions 38

39 Additional information example: USA TSCA TSCA 8(e) Penalties for PFOA (perfluorooctanoic acid) $10.25 million penalty to DuPont $1.52 million reduced penalty to 3M for 244 violations under an EPA compliance incentives policy allowing self-disclosure and voluntary audit How does a $25,000* maximum penalty get so huge? Multiplier: per day Multiplier: per violation *Note: penalties increase for inflation, current penalty max = $38,114 Source: Publication EPA-325-F , Enforcement Alert: Failure to Report Chemical Risks Can Result in Major Fines 39

40 REACH Safe use information to global users In-house Database IUCLID Bulk XML REACH-IT C&L Notification Registration Company files ECETOC TRA PETRORISK ConsExpo EUSES (Env) CHESAR +Plug-ins Supply chain FEEDBACK LOOP Free Software Commercial Software 40

41 Summary: from the roots of REACH, chemical control obligations grow globally Reaction, Evolution, and Additional Information on CHemicals 41

42 Thank You 42