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Chemicals QuarterlyQ4 2013

Presented by Stacey Bowers, MILS15 January 2014

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Maine proposes reporting rules

• Maine’s Department of Environmental Protection (DEP) has proposed four rules to implement the State's Toxic Chemicals in Children’s Products– Cadmium, formaldehyde, mercury, and arsenic

would be listed as priority chemicals– Manufacturers would be required to report the

intentional use of these chemicals over minimum levels in specified products 

• The Department held hearings on the proposed rules yesterday

• The deadline for public comment is 31 January 2014

3

Washington State amends Reporting Rule

• Washington State’s Department of Ecology is adopting amendments to the Children's Safe Products - Reporting Rule

• The rule applies to companies that make children's products, such as toys, cosmetics, jewelry, and baby products

• The amendment adds TDCPP to the list of chemicals of high concern to children and removes n-butanol from the reporting list

• The presence of TDCPP must be reported in all notices required to be filed after 31 August 2014

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Vermont considers restrictions on chemicals of high concern

• Vermont's Senate is considering S.239, An act relating to the regulation of toxic substances

• The bill would require the Department of Health to identify and publish a list of chemicals of high concern

• The bill would also require manufacturers of consumer products containing a chemical of high concern to notify the Commissioner of Health of the use of the chemical in the product and to replace the chemical with a safer alternative

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Denmark amends phthalate order

• The Danish Environmental Protection Agency amended Order No. 1113 of 26 November 2012

• The Order prohibits the import of electrical and electronic equipment containing phthalates

• The amendment postpones the ban to 1 December 2015, instead of 2013

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California’s OEHHA adds DINP to Prop 65

• California’s Office of Environmental Health Hazard Assessment (OEHHA) added diisononyl phthalate (DINP) to the list of chemicals known to the state to cause cancer

• The Carcinogen Identification Committee (CIC) determined that the chemical was shown, through scientifically valid testing according to generally accepted principles, to cause cancer

• Butyl benzyl phthalate (BBP) was considered but not added to the list

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TDCPP & TCEP settlements under Prop 65

• In Q4 2013, several new settlements for stuffed and upholstered products containing chlorinated flame retardants were finalized

• The settlements: – Apply to products such as car seats, play yards and

bassinets, as well as back cushions, chairs with padded seats and benches;

– Establish a limit of 25 ppm of each Tris(1,3-dichloro-2-propyl)phosphate (TDCPP) and/ or tris(2-carboxyethyl)phosphine (TCEP) in any material, component or constituent of a covered product;

– Require testing to EPA 3545 and 8270C, or equivalent methodologies, conducted by a laboratory accredited by the State of California or similar nationally recognized accrediting organization and

– Allow labeling for existing inventory only

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Prop 65 60-day notices in Q4 2013

• California’s Attorney General received 216 60-day notices in Q4 2013

• Chemicals– DEHP was the most-notified chemical, with 113 notices– Lead and lead compounds were second, with 45 notices– Ethyl alcohol in alcoholic beverages was third-most notified, with 20

notices• Products

– The product most notified against was alcoholic beverages, with 20 notices

– Eyewear was second-most-notified, with 17 notices– Dietary supplements were third-most-notified, with 14 notices

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ISO drafts standard on phthalates in toys

• The International Organization for Standardization (ISO) has issued a new draft standard to restrict phthalates in toys and children's products– ISO/DIS 8124-6, Safety of toys – Part 6: Toys and children's products –

Determination of certain phthalate esters in toys and children's products• The draft standard is "Under development" and is not yet available

for review

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CEH report on flame retardants

• Center for Environmental Health (CEH) tested 42 children’s furniture products containing polyurethane foam in the US and Canada from a number of major retailers

• Flame retardant chemicals were found in 38 of the 42 products:– Two products contained more than one of these flame retardants

• Four retardants were found:– Firemaster 550 or equivalent– Tris (1-chloro-2-propyl) phosphate (TCPP)– Tris (1,3-dichloro-2-propyl) phosphate (Tris or TDCPP)– Butylated Triphenyl Phosphate

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Call for evidence on substituting DecaBDE

• The European Chemicals Agency (ECHA) called for information to identify uses of Decabromodiphenyl ether (DecaBDE), in cases where substitution may be challenging

• The information will be used to assess feasible alternatives in the preparation of an Annex XV restriction dossier

• Available information suggests that it is technically possible to substitute DecaBDE in its common uses such as in plastics, polymers, composite materials and by the textile industry

• Comments were due by 15 December 2013

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Restriction on chromium VI in leather

• The European Commission’s (EC) REACH Comitology Committee has voted to adopt EU proposals to restrict chromium VI in leather articles

• The Commission notified the World Trade Organization (WTO) in July of its proposals

• The draft would amend REACH to establish a limit of 3 ppm chromium VI in leather articles coming into contact with the skin

• The restriction has yet to be formally adopted by the EC and Parliament

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Greenpeace on ‘monsters in the closet’

• Greenpeace released an investigation on hazardous chemicals in children’s clothing and footwear across a number of major brands

• Eighty-two children’s textile products were tested for nonylphenol ethoxylates (NPEs), phthalates, organotins, per/poly-fluorinated chemicals (PFCs) and/ or antimony

• All of the chemicals were detected, above the technical limits of detection used in thestudy

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NGO report on chemicals in feminine-care products

• A report, “Chem Fatale,” from the US group Women’s Voices for the Earth (WVE) details the potential hazards of chemical ingredients in feminine-care products

• The report says these products may include chemicals such as formaldehyde-releasing compounds, parabens, benzocaine, adhesive and coloring agents linked with allergic reactions, endocrine disruption and other health effects

• The group is calling for greater oversight of these products by the Food & Drug Administration (FDA), including full disclosure of their ingredients, such as fragrances

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NGO testing of chemicals in consumer products

• Healthystuff.org tested 143 consumer products purchased from 11 national retailers– Products ranged from household, kitchen, outdoor and office supplies to

exercise equipment, clothing and jewelry• Chemicals tested included heavy metals, phthalates, and flame

retardants– More than three quarters (115 of 143) of the products contained at least

one or more chemicals of concern at detectable levels (>40 ppm)– One-third (47 of 143) had three or more chemicals of concern at

detectable levels

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EU amendment on PAHs in consumer products

• The EU issued Commission Regulation (EU) No 1272/2013 to amend its restrictions on Polycyclic Aromatic Hydrocarbons (PAHs)

• The Regulation restricts rubber or plastic components that come into direct, prolonged or short-term repetitive contact with the human skin or the oral cavity that contain more than 1 mg/kg of any of the listed PAHs

• Additionally, it prohibits toys and childcare articles containing any of the PAHs in concentrations greater than 0.5 mg/kg in their accessible plastic or rubber parts

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Brazil to ban BPA

• The National Institute of Metrology, Quality and Technology (Inmetro) opened a public consultation on a proposed revision of its requirements for baby bottles and nipples

• Bisphenol A (BPA) will be banned in baby bottles• Manufacturers and importers will still need to report on the presence

of natural latex• Manufacturers will have 12 months to conform

to the new rules after final publication

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EU food chemical exposure assessment tool

• C&R data partner, Chemical Watch, reports that the EU 7th Framework Programme has released a food chemical exposure assessment tool

• The tool is called Flavourings, Additives and food Contact materials Exposure Task (FACET)

• FACET delivers a food chemical exposure surveillance system for additives, flavorings and food contact materials

• The tool enables realistic estimates of consumer exposure to migrants from food packaging, using computational tools and data on the composition of packaging, packaging usage and food consumption

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EFSA opinion on recycled PET in food contact

• The European Food Safety Authority's (EFSA) published a scientific opinion evaluating the safety of various recycling processes for polyethylene terephthalate (PET) used in food contact materials

• The panel concluded that the recycled PET obtained from the processes poses no risk to consumers

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Amended EU Batteries Directive summary

• C&R data partner, Paul Goodman, from ERA Technology Ltd, has provided a summary of the amended European Union's (EU) Batteries Directive

• The amended Directive, 2013/56/EU, makes several changes:– The exemption that allows up to 2% mercury in button cells will end on

1 October 2015;– Article 11, which requires equipment to be designed so that used

batteries can be removed at end of life (of the battery) for separate recycling, has been clarified and

– A new Annex IV has been added, to list the procedural requirements for registration and harmonize producers' obligations

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European Commission memo on mercury

• In October, the European Commission (EC) released a memo of questions and answers on the EU Mercury Policy

• On 10 October 2013, the EU signed the new Minamata Convention on Mercury, which covers the whole mercury life-cycle

• The EC will assess in detail the implications of the Minamata Convention for EU policy and legislation

• This process will also include stakeholder consultation

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Amendments to RoHS Directive on exemptions

• In October 2013, the European Commission (EC) passed 16 amendments to the RoHS Directive, each relating to exemptions

• The Directives establish amendments for productssuch as:– Lead as an alloying element for medical equipment

exposed to ionizing radiation;– Cadmium in phosphor coatings in image intensifiers for X-ray images;– Lead in solders and coatings of electrical and electronic components;

and– Mercury in single capped compact fluorescent lamps (CFLs) for general

lighting purposes

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RAC and SEAC agree on EU lead restrictions

• The European Commission’s (EC) Committee for Risk Assessment (RAC) and Committee for Socio-economic Analysis (SEAC) agreed on a Swedish proposal to restrict lead in consumer articles

• The proposal would restrict lead and its compounds in consumer articles that can be placed in the mouth by small children

• SEAC plans to adopt its final opinion in March 2014 after a 60-day public consultation

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Efforts to eliminate lead paint

• The World Health Organization (WHO) is calling on countries to strengthen national actions to eliminate lead paint

• It is believed that lead paint is a major contributor to the 143,000 deaths per year result from lead poisoning

• Thirty countries have phased out the use of lead paint. The goal is to be up to 70 countries by 2015

• Additionally, in Thailand, Health Promotion Foundation, an independent agency, held a program on lead in paint policies and the effects of lead paint on children

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EU draft regulation on biocidal products

• The European Commission’s (EC) Permanent Representatives Committee approved a compromise agreed with the European Parliament on a draft regulation amending the Biocides Regulation

• The draft Regulation aims to remove unintended market barriers for suppliers of new articles treated with biocidal products and for a large number of suppliers of biocidal active substances

• The draft Regulation must be formally approved by the European Parliament and the Council

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ECHA consultation on a biocidal active substance

• The European Chemicals Agency (ECHA) has initiated the first public consultation under the Biocidal Products Regulation

• The consultation will be on the active substance dinotefuran which is proposed to be used in biocidal products of product-type 18 (e.g., insecticides, acaricides and products to control other arthropods)

• The consultation is open until 28 January 2014

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Action urged for EU nanomaterial regulation

• During a meeting on Nanomaterials, the European Commission (EC) was urged to speed up its actions on the nanomaterial regulation

• The EC had been expected to come forward with draft measures by the end of 2013

• The Commission presented a document outlining the issues related to amending the REACH annexes, including:– the substances that should be covered in a dossier, namely nanoforms;– endpoints for nanomaterials;– read-across and grouping and – registration exemptions

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Nanotechnology association launches database

• The Nanotechnology Industries Association (NIA) has launched a Regulatory Monitoring Database

• The tool lists nano-specific regulations and standards from around the world

• It also features analysis of legislative documents related to nanotechnology

• NIA members and non-members can access the database by subscribing to it on their website

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EU nano governance project launches website

• NanoDiode, a European FP7 project aimed at promoting a dialogue on effective governance of nanotechnology across Europe, has launched its website

• The project started in July and will run for three years

• The aim is to bring together representativesfrom industry, technological and social research, policy, civil society, education and media to engage

with society on nanotechnology

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Authorities & industry say REACH is ‘full of holes’

• At a conference organized by Anec, European national authorities and downstream industry said REACH is not enough to protect consumers from hazardous chemicals in articles

• According to the meeting, REACH gaps that need to be filled are:– materials in contact with drinking water;– emissions to indoor air;– textiles; and– toys

• Attendees called for support from the European Union's (EU) Directorates General of Enterprise and Environment

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ECHA report on REACH enforcement project

• The European Chemicals Agency (ECHA) issued the final report of its second Regulation on REACH enforcement project

• The project – REF-2 – focused on checking the compliance of downstream users, particularly formulators of mixtures

• The project found that 67% of the inspected companies were non-compliant with one or more provisions of REACH or CLP– Non-compliance was most commonly related to contraventions of

(pre-) registration (REACH, 8%), notification (CLP, 15%), failure to keep information (20%) and having deficient risk management measures (12%)

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ECHA 'Guidance in a Nutshell' on REACH

• The European Chemicals Agency (ECHA) has produced a series of shortened versions of its REACH Guidance Documents, to make the guidance more accessible for industry

• The “Guidance in a Nutshell” address: – obligations for downstream users; – compilation of safety data sheets;– data sharing;– identification and naming of substances;– requirements for substances in articles;– registration and– chemical safety assessments

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ECHA adds 7 new Candidate SVHCs

• In December 2013, the European Chemicals Agency (ECHA) added seven new substances to the Candidate List of Substances of Very High Concern (SVHC) for Authorisation

• Carcinogenic substances included:– Cadmium sulphide– C.I. Direct Red 28– C.I. Direct Black 38

• Toxic for reproduction substances included:– Dihexyl phthalate– Lead di(acetate)– Trixylyl phosphate

• The list now totals 151 Candidate SVHCs

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ECHA updates website on SVHC Roadmap

• The ECHA has added a designated section with information on the plan to implement the SVHC Roadmap to 2020

• SVHC Roadmap 2020 focuses on finding new potentially relevant substances of very high concern with carcinogenic, mutagenic and toxic for reproduction, sensitizing, very persistent and very bioaccumulative and/ or endocrine disrupting properties

• This Roadmap aims to have all relevant substances of very high concern included in the Candidate List by 2020

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ECHA considers amendment on restriction on cadmium in paints

• The European Chemicals Agency (ECHA) has opened a public consultation to amend the REACH Regulation restriction on cadmium and its compounds in paints

• The proposal recommends extending the restriction such that cadmium and its compounds shall not be used, or placed on the markets in paints if the concentration of cadmium (expressed as Cd metal) is greater than 0.01% by weight

• Currently, only "use" is restricted and there is no concentration limit• ECHA will accept comments through 17 June 2014

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Update on South Korea’s K-REACH

• C&R data partner, Kim, Choi & Lim, has issued an update on South Korea’s Registration, Evaluation, Authorization, and Restriction of Chemicals Act (K-REACH)

• Korea’s Ministry of Environment formed a K-REACH Subordinate Statutes Council in September 2013, issuing preliminary opinions on matters including:– Manufacture and import of chemicals for R&D purposes, without

registration;– Reduced registration requirements for production and import of

chemicals in quantities below 1 ton;– Provision of information within the supply chain and– Clarification of chemicals to be registered

• For more, contact me directly!

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Japan assesses Class 1 chemicals

• Japan’s Ministry of Economy, Trade and Industry (METI) is seeking chemical assessments in relation to the Chemical Substance Control Law and the Stockholm Convention on Persistent Organic Pollutants

• The chemicals being surveyed are:– polybrominated diphenyl ethers (PBDE) in flame resistant products;– perfluorooctanesulfonate (PFOS) – polychlorinated naphthalenes

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EurAsEC RoHS proposed

• The Eurasian Customs Union (EurAsEC), which includes Russia, Belarus and Kazakhstan, is in the process of changing its legislation for electrical equipment

• These new technical regulations will not enter force before February 2015

• The proposed scope is similar to the European Union’s (EU) RoHS and includes household appliances, IT and telecom equipment, office equipment, tools and lighting

• The same six substances as EU RoHS will be restricted, with the same concentration limits

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Taiwan standard on electrical and electronic equipment

• Taiwan’s Bureau of Standard, Metrology and Inspection (BSMI) has announced a new standard on the restrictive use of chemical substances in electrical and electronic equipment (EEE)

• The aim is to bring Taiwan in line with the EU• CNS 15663, Guidance to reduction of the restricted chemical

substances in electrical and electronic equipment, includes restricted substances, maximum concentration values and marking for EEE

• The standard is voluntary

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China issues guidelines for chemical testing

• In September, the remaining three volumes of a revised version of China's Guidelines for the Testing of Chemicals were published

• The new edition adds 68 test methods and updates 34 existing methods

• There are four volumes, including one previously published in June of 2013:– Volume I: Physical-chemical properties and physical hazards– Volume II: Effects on biological systems – Volume III: Degradation and accumulation volume – Volume IV: Health Effects

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Thailand publishes hazardous chemical list

• The Thailand Food and Drug Administration published a new list of hazardous substances

• The new publication combines several lists into one document as well as adding new chemicals

• Lists within the document are organized by the government department responsible

• Chemical names appear in Thai and English

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US House Committee hearing on TSCA preemption

• In September, the US House Energy and Commerce Subcommittee on Environment and the Economy convened a hearing on the “Regulation of Existing Chemicals and the Role of Pre-Emption under Sections 6 and 18 of the Toxic Substances Control Act”

• The focus was on issues such as: – regulatory implementation; – implications of TSCA requirements related to the manufacture and

processing of existing chemicals and – federal preemption of state law

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Documentary on chemicals in household products

• The October 2013 issue of the ECHA Newsletter featured the American documentary, The Human Experiment

• According to director Dana Nachman, “The documentary is about the thousands of chemicals we all use in our everyday products, some of which are in our furniture, our make-up and other cosmetics, and how in America, the majority of these chemicals have never been tested for safety”

• Nachman discusses the Toxic Substances Control Act (TSCA) and as well as state-level restrictions on chemicals like bisphenol A (BPA)

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 NGOs release alternatives assessment guidance

• A group of United States businesses, non-governmental organizations and academics, known as BizNGO, has released "Common Principles for Alternatives Assessments"

• It is a set of principles to guide best practices for conducting alternatives assessments

• The principles are designed to guide for informed decision making to support reducing hazardous products, phase in safer substitutes and eliminate hazardous chemicals where possible

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 IC2 publishes Alternatives Assessment Guide 1.0

• Interstate Chemicals Clearinghouse (IC2) has published a guide to help stakeholdersevaluate alternatives to toxic chemicals in products

• The “IC2 Alternatives Assessment Guide” is built on the alternatives assessment process pioneered by the US Environmental Protection Agency’s (EPA) Design for the Environment Program, as well as best practices from industry

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California DTSC public meetings

• California’s Department of Toxic Substances Control (DTSC) began a series of public meetings in December 2013

• The agency is providing legislative updates, with particular focus on implementation of its Safer Consumer Product Regulations, for stakeholders

• C&R issued a white paper on the Regulations in November 2013• Additionally, we’re talking with DTSC about co-hosting a webinar on

the Regulations• For more, contact me directly!

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Washington launches green chemistry center

• Washington State's Department of Ecology has launched a regional green chemistry center

• It aims to advance environmentally preferable alternatives to substances of concern in the Pacific Northwest

• The center will focus on projects that advance green chemistry as part of the state’s pollution prevention initiatives

• The center’s advisory board is expected to select and prioritized projects and could include work on antifouling marine paints, halogenated retardants and ink and paint pigments

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