REACH and RoHS updates for EU and Asia Pacific countries Mike McNally Antea Group

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1 REACH and RoHS updates for EU and Asia Pacific countries Mike McNally Antea Group

2 Agenda Overview REACH RoHS Related regulations Discussion: Key Risks Key Considerations

3 Overview We have witnessed an unprecedented global growth in product regulatory requirements during the past ten years. These legislative initiatives have set significant compliance challenges for industry while at the same time creating new opportunities for innovation and growth.

4 REACH European Union REACH Regulation on chemicals and their safe use Came into effect June 2007 REACH-like legislation enacted globally: Several countries (including China, Korea, Malaysia, Australia, New Zealand) have implemented REACH-like regulations Several others (including the U.S.) are considering REACH-like legislation

5 REACH in the EU REACH objectives: protection of human health and the environment enhance competitiveness and innovation free circulation of substances (internal market) promotion of alternative methods (substitution) The main obligations have been phased-in since 2007 and will continue until 2018

6 REACH in the EU Core elements: Registration of substances 1 tonne/yr Communication in the supply chain Evaluation of some substances by Member States Authorization only for substances of very high concern Restrictions to address unacceptable risks European Chemicals Agency, ECHA manages system Focus on priorities: high volumes (as a proxy for potential risk) greatest concern (substances & uses with highest risk) Shift of responsibilities from public authorities towards industry

7 REACH and related legislation REACH aims to ensure that the risks presented by substances are adequately controlled throughout their whole life cycle, including those occurring in the waste stream. REACH applies to all substances as such, in mixtures or in articles, including substances in electrical and electronic equipment (EEE) within the scope of RoHS. The CLP legislation addresses the Classification, Labeling and Packaging of substances and mixtures and thus is a important counterpart to REACH.

8 Important terms Substance: A chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. Preparation: A mixture or solution composed of two or more substances. Article: An object which during production is given a special shape, surface, or design which determines its function to a greater degree than does its chemical composition. Import: Physical introduction in to the territory of the Community. An Importer is any natural or legal person established within the Community which is responsible for import. Manufacture: Production or extraction of substances in the natural state. A Manufacturer is any natural or legal person established within the Community who manufactures a substance within the Community.

9 Important terms Use: Any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from 1 container to another, mixing, production of an article or any other utilization. Exposure Scenario: The set of conditions, including operational conditions and risk management measures that describe how the substance is manufactured or used during its life cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures to humans and the environment. CMR: Carcinogenic, Mutagenic, Reproductive toxicity (human health hazards). PBT: Persistent, Bio-accumulative, Toxic (environmental health hazards).

10 M REACH compliance responsibilities Obligation: Registration of substances in articles Notification of substances in articles Communication of information on substances in articles legal basis in REACH Regulation Article 7(1) Article 7(2) Article 33 actors concerned article producers and article importers article producers and article importers article suppliers substances concerned substances intended to be released from articles substances included in Candidate List of Substances of Very High Concern for authorization substances included in Candidate List of Substances of Very High Concern for authorization tonnage threshold 1 ton per year 1 ton per year - concentration in article threshold - 0.1% (w/w) 0.1% (w/w) exemption from obligation possible on the basis of: substance already registered for that use yes yes no exposure can be excluded no yes no

11 China Order No. 7 of MEP came into force on 15 Oct and stipulates that new chemical substances have to be notified to CRC, irrespective of annual tonnage Notification applies to: substances as such or in articles (intended to be released) ingredients or intermediates for pharmaceuticals, pesticides, veterinary drugs, cosmetics, food and feed additives Exemptions: chemicals subject to other existing laws and regulations substances existing in nature (unprocessed or processed only physically) substances of noncommercial purpose or unintentionally produced special categories IMPORTANT: Polymers are not exempt from notification, even if all monomers are listed in IECSC!

12 China There are no specific compliance responsibilities under China REACH for the manufacturers of articles. It is however important to verify the compliance status of key substances used in products being manufactured in or being imported into China.

13 Korea The Act on the Registration and Evaluation of Chemicals (AREC) passed the plenary session of the National Assembly in Korea on April 30, 2013 and came into force on January 1, 2015 Provisions: Registration of existing and new chemical substances Screening of hazardous chemical substances Hazard and risk assessment of products containing chemical substances and hazardous substances Sharing information of chemical substance

14 Korea Product Management and Compliance under Korea REACH: K-REACH has special provisions for products. A product means an item used by an end user or its component or part with a possibility to cause consumers to be exposed to a chemical substance and the product could be a preparation or an article. There are two requirements for products: product notification and risk assessment. Product Notification obligations apply if: A product contains a hazardous substance in a concentration above 0.1% w/w; and total volume of the hazardous substance manufactured/imported exceeds 1t/y. Exemptions from Product Notification - There are two types of exemptions. One type does not require prior confirmation while the other one requires companies to apply for prior confirmation on exemption. Exemptions not requiring confirmation.: Articles that do not contain any substances intended to be released during its use; Exemptions requiring prior confirmation Exposure to humans or the environment can be excluded when a product is normally used; A hazardous substance has already been registered for the use in a product. There are also risk assessment provisions that apply to certain consumer and biocide products that are subject to notification

15 EU RoHS Directive 2011/65/EU (RoHS) on the Restriction of the use of certain Hazardous Substances in electrical and electronic equipment (EEE) entered into force on 21 July 2011 and Member States were obliged to bring national implementing measures into effect by 2 January Article 1 of RoHS states that the aim of the Directive is to contribute "to the protection of human health and the environment, including the environmentally sound disposal of waste electrical and electronic equipment (EEE)". Note that the Directive does not apply to EEE that is subject to the Directive 2000/53/EC on end-of-life vehicles (ELV).

16 Eu RoHS EU RoHS is closely linked with the Waste Electrical and Electronic Equipment Directive (WEEE) 2002/96/EC which sets collection, recycling and recovery targets for electrical goods. It is also similar to the End of Life Vehicles (ELV) regulation, which prohibits the use of these same 6 hazardous substances in vehicles sold after July 2003.

17 RoHS Several other countries have implemented legislation modelled on EU RoHS. These include China, Korea, Japan. The state of California has also implemented legislation modelled on RoHS.

18 RoHS Six substances are targeted by both EU & China RoHS. Lead Mercury Cadmium Hexavalent Chromium Polybrominated Bi-Phenols (PBB) Polybrominated Diphenyl Ethers (PBDE)

19 RoHS Maximum Concentration of Restricted Substances allowed are: 0.1% by weight in homogenous material for all. 0.01% by weight in homogenous material for cadmium. Numerous exemptions available by EU RoHS. Hardly any exemptions offered by China RoHS.

20 Related regulations Important regulations that are related to REACH and RoHS include: CLP - Regulation (EC) No 1272/2008 on the Classification, Labeling and Packaging of substances and mixtures. CLP integrated the United Nations globally harmonized system (UN GHS) for classification and labeling of chemicals into Europe. CLP entered into force on 20th January CLP establishes the requirements for classification and labeling, while REACH sets the requirements for risk assessment and safety data sheet (SDS) content. GHS in other countries including the U.S. (OSHA Hazard Communication Standard.

21 Related regulations WEEE - The European Waste Electrical and Electronic Equipment Directive (WEEE) applies to a wide range of electronic and electrical products. WEEE encourages the collection, treatment, recycling and recovery of waste electrical and electronic equipment. WEEE makes producers and importers responsible for financing of the collection, treatment and recovery of WEEE and sets targets for the member states.

22 Related regulations Packaging legislation - Under Article 9 of Directive 94/62/EC, all packaging placed on the EU market must comply with essential requirements concerning the packaging s: manufacturing and composition; reusable nature; and recoverable nature Responsibility for compliance under Directive 94/62/EC the responsible party must comply with the Directive when the packaged goods are placed on the market in any EU Member State. Responsible parties can include: suppliers of packaging materials; packaging producers and converters; fillers and users; importers; and traders and distributors The responsible party is obliged to ensure that all packaging covered by Directive 94/62/EC, complies with the: essential requirements, which includes the: manufacture and composition of the packaging; and reusable and recoverable nature marking requirements collection and recycling requirements

23 Discussion - Key Risks Risks associated with product regulatory compliance can include: Compliance risks Supply chain risks Market risks

24 Discussion Key Considerations Key points to consider to manage risks and create opportunities include: Tracking regulatory changes and trends Recording and reporting Compliance assurance Supply chain communication and management Customer communication

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