Top International News in Chemical Policy and Regulation- September 2017: Europe, Americas, Asia
Canada Publishes Results Of Prioritization Of The Revised In Commerce List: On August 10, 2017, Canada published the results of its prioritization of the Revised In Commerce List (R-ICL) with supporting rationale. Substances on the R-ICL include substances in pharmaceuticals, veterinary drugs, cosmetics, biologics, food products, natural health products, and medical devices. Under the Chemicals Management Plan (CMP), Health Canada prioritized substances on the R-ICL to identify those that require further evaluation to determine whether they pose a risk to human health or the environment. Health Canada applied the prioritization process to approximately 3,500 substances to separate those that are unlikely to require further work based on information available at the time from those that represent priorities for risk assessment or that require further information. Approximately 25 percent of the substances were prioritized for further evaluation, while the remaining 75 percent were of reduced priority in the context of the R-ICL. Canada notes that reduced priority does not preclude actions being taken under other Canadian Environmental Protection Act (CEPA) initiatives. Reduced priority substances that are on the Domestic Substances List (DSL) have been deleted from the R-ICL.
Canada Publishes Information Received In Response To Several Section 71 Surveys: On August 29, 2017, Canada published information received in response to certain notices published in the Canada Gazette under CEPA Section 71 targeting chemical substances of interest under the CMP. Canada states that some information gathered was considered confidential business information (CBI) by submitters, and Canada masked the CBI prior to publication. Canada notes that these documents do not include an assessment of the potential risks these substances may represent for the environment or the health of Canadians.
China Amends Data Requirements For New Chemical Notification: On August 31, 2017, the Ministry of Environmental Protection (MEP) published the Amendment on Data Requirements for China New Chemical Notification. The Amendment will take effect October 15, 2017. The Amendment on Data Requirements includes the following five tables:
Table 1. Minimum requirements of toxicological data;
Table 2. Minimum requirements of eco-toxicological data;
Table 3. Exemption conditions of physico-chemical data;
Table 4. Exemption conditions of toxicology testing data; and
Table 5. Exemption conditions of eco-toxicology testing data.
The China Solid Waste and Chemical Management Center (SCC) will conduct trainingon the Amendment on September 25-27, 2017. More information on the Amendment is available in our memorandum, “Revised Data Requirements for China New Chemical Notification Released.”
Testing Identifies Suspected EDCs In Pushchairs: On August 3, 2017, the Danish Consumer Council’s THINK Chemicals initiative issued a press release entitled “Pushchairs: These problematic chemicals were found in test.” The press release states that 11 pushchairs were tested for unwanted chemicals in the seat and handle by THINK Chemicals. THINK Chemicals states that “[i]n the test [four] pushchairs receive the best assessment. The pushchair Britax B-motion 4 plus performs best in the test … [Three] other pushchairs also receive top marks. In these products only very small amounts of so-called [polycyclic aromatic hydrocarbons (PAH)] were present in the handle.”
THINK Chemicals stated that six pushchairs, identified below, received the lowest mark on the test because of the content of “problematic substances” such as chlorinated paraffins, the flame retardant Tris (1-chloro-2-propyl) phosphate (TCPP), or a “PAH called naphthalene.” These substances were found in the handles or seat. THINK Chemicals indicated that the aforementioned problematic chemicals are not banned in baby products, however, naphthalene is classified as possibly carcinogenic. THINK Chemicals provided that chlorinated paraffins are on the Danish Environmental Protection Agency’s list of “unwanted substances” and are suspected endocrine disrupting chemicals (EDC). THINK Chemicals indicates that TCPP is banned in the European Union (EU) in toys for children from zero to three years old because it “can be carcinogenic.”
THINK Chemicals stated that for the reasons identified above, the substances are “problematic in baby products such as pushchairs.” THINK Chemicals states that exposure in a single product is not necessarily problematic in itself, but such exposure contributes to children’s combined exposure to unwanted chemicals from many different sources. THINK Chemicals stated that it is a “good idea to minimize the exposure when possible -- especially in baby products.”
Britax B Motion 4 Plus, Baby Jogger City Premier, Basson Baby Uno, and Joie Litetrax 4 received the “best assessment (A)” from THINK Chemicals. Hauck Rapid 4 received a “middle assessment (B),” and Britax Smile 2, Cybex Balios M, Gb QBIT Plus, Maxi Cosi Stella, Mutsy Nexo, and Phil and Teds Smart received the “lowest assessment (C).”
THINK Chemicals’ test also researched content of unwanted phthalates in the pushchairs, and no phthalates were found in the 11 tested products. More information is available, in Danish, in the “full test with product pictures.”
KEMI Identifies 37 Bisphenols As Potential EDCs: Kemikalieinspektionen (KEMI), the Swedish Chemicals Agency, issued a press release and report, in Swedish, to indicate that its investigation has found that 37 of 39 bisphenols surveyed on the European market could have potential endocrine disrupting properties. KEMI adopted a screening method that groups substances based on their chemical structure, possible use in different applications, and potential endocrine disrupting properties according to data simulations.
Following imposition of EU-wide restrictions on BPA, KEMI indicates in its press release that over 200 chemical substances have a similar chemical structure to BPA. KEMI states that 37 of these substances may have hormone-disrupting properties similar to those of BPA, and that these substances may be used in a manner that could lead to consumers being exposed. KEMI further observes that the following six substances have health characteristics and usage patterns that present challenges from a risk perspective:
Risk Management Option Analyses have been initiated under REACH for these six substances, and Bisphenol AF and Tertramethyl Bisphenol F. KEMI states that as the six substances are currently being handled under REACH, it does not propose new national restrictive rules for use of the substances in Sweden.
KEMI indicates that information on the toxicological effects of half of the 39 analyzed substances is inadequate or entirely missing, and that this is problematic because, according to data simulations, all bisphenols selected for the survey can have endocrine disrupting properties similar to BPA.
KEMI found that there is reason to continue reviewing the group of bisphenols, and indicated that it should actively disseminate results to researchers and other authorities. KEMI will also inform affected companies and industries in Sweden of results, and if needed, initiate dialogue with the companies.
Turkey REACH Documents Available In English: As reported in our Global Regulatory Update for August 2017, on June 23, 2017, Turkey’s Ministry of Environment and Urbanization (MoEU) published its REACH-like KKDIK Regulation. As reported in The Acta Group’s memorandum entitled “Turkey Catching Up with the [EU’s REACH] Regulation,” the name “KKDIK” is derived from the first letters of “Registration,” “Evaluation,” “Authorization,” and “Restriction” in Turkish. Similar to EU REACH, KKDIK requires companies to register substances manufactured in Turkey or imported into Turkey in quantities of greater than one metric ton per annum within prescribed deadlines. Turkey recently posted English translations of several Turkey REACH documents on its website:
KKDİK Yönetmeliği -- İngilizce (Draft By-Law on Registration, Evaluation, Authorization and Restriction of Chemicals);
KKDİK - Ek 18 -- İngilizce (Annex 18: Conditions for Receiving Certificate of Competency of Chemical Assessment Expert); and
KKDİK - Ek 17 -- İngilizce (Annex 17: Restrictions on the Manufacture, Placing on the Market and Use of Certain Dangerous Substances, Mixtures and Articles).
Turkey Introduces New Controls On Restricted Chemicals In Footwear: Turkey has announced customs controls on restricted substances in imported footwear. The restrictions were passed in 2015, and entered into force on July 10, 2017. The restrictions concern Chromium VI, Dioctyltin, and the phthalates Benzyl Butyl Phthalate (BBP), Dibutyl Phthalate (DBP), Bis(2-ethylhexyl) Phthalate (DEHP), Diisodecyl Phthalate (DIDP), Diisononyl Phthalate (DINP), and Di-n-octylphthalate (DNOP).
The restrictions include:
Chromium VI in accessible leather parts is limited to 3 mg/kg;
Dioctyltin in footwear or its components, intended to come into skin contact, has a concentration limit of 0.1 percent (weight by weight); and
The relevant phthalates in accessible and inaccessible parts have a concentration limit of 0.1 percent.
Additional information is available, in Turkish, in the Restrictions List.
UNITED KINGDOM (UK)
Brexit Moves Forward, Government Issues Papers, And CIA Provides Comments: As the EU Withdrawal Bill, formerly referred to as the Great Repeal Bill, won its Commons vote by 326 to 290, despite critics warning that it presented a “power grab” by ministers, the UK took a significant step towards ending the supremacy of EU law in the UK on September 12, 2017. Prime Minister Theresa May welcomed the Commons vote, stating the Bill offered “certainty and clarity.” The EU Withdrawal Bill overturns the European Communities Act 1972 and will convert existing EU laws into UK law to ensure there are no gaps in legislation on Brexit day. The Bill will now receive line-by-line scrutiny in its committee stage. UK Members of Parliament (MP) voted in favor of the Government’s proposed timetable for debating the legislation -- by 318 votes to 301 -- guaranteeing 64 hours of debate over eight days. The Bill’s committee stage will commence when MPs return to Parliament after their party conferences.
In July, the UK’s Environment Minister Thérèse Coffey, Ph.D. stated that the UK intends to secure a “mutual recognition” agreement on chemicals policy with the EU prior to Brexit, indicating that regulatory equivalence was a priority for the UK. Dr. Coffey stated in July that it would be in the interests of the UK and the EU to recognize validity of pre-Brexit REACH registrations submitted by UK entities following Brexit, particularly considering that the REACH registration process is complex and UK companies have already invested heavily in it. Subsequently, the UK Government issued a position paper entitled “Continuity in the availability of goods for the EU and the UK.”
The Government’s position paper provides under “Principle B: Where businesses have undertaken compliance activities prior to exit, they should not be required to duplicate these activities” that businesses “will have undertaken a number of complex, lengthy and often costly procedures” to place goods on the EU market. The position paper states “[t]his could include, for example, undergoing an inspection by an [EU-recognized] body to ensure production is in accordance with Good Manufacturing Practice or collecting and submitting data on the hazards and risks of a chemical substance … The Withdrawal Agreement should [recognize] the validity of this compliance activity where it has taken place prior to exit. This should be [recognized] for both the UK and EU markets regardless of where the activity took place, and it should be [recognized] for the full time period or type of products intended when the compliance activity was undertaken.”
In response to the Government’s position paper, the UK’s Chemical Industries Association (CIA) issued a press release entitled “Chemical industry supports Government's approach on goods availability.” In the press release, Steve Elliott, Chief Executive of CIA, stated: “I think the Government is taking exactly the right approach in this area, acknowledging the need for chemical businesses to be reassured that significant regulatory commitments and related costs, such as those already undertaken under REACH, will remain valid after exit from the EU. The approach outlined by [the] Government confirms where businesses have undertaken compliance activities prior to exit, they should not be required to duplicate these activities in order to place goods on the UK and the EU market after exit. This includes [recognizing] the validity of type approvals, certificates and registrations issued prior to exit … Accepting the ongoing validity of all pre-departure registration activities marks a significant step in securing that outcome.”
The UK Government also issued a “future partnership paper” entitled “Future customs arrangements” prior to the aforementioned position paper. CIA criticized this customs paper in its press release, “Government making transition too complicated says top manufacturing exporter,” on the grounds that an interim Customs Union following Brexit could bring uncertainty. CIA suggested that the UK Government is “making the full transition to Brexit unnecessarily complex,” and that the UK’s chemicals industry is affected significantly by this.
CIA recently indicated that it supports the UK remaining “in” all REACH processes following Brexit, including Authorization and Restriction. CIA provides that there are strong commercial interests, in addition to environmental health and safety concerns, that drive its view.