California: Bisphenol A Still Present in Cans

The number of cans containing BPA sold in typical U.S. grocery discount stores, like Kroger, Albertsons, Dollar Tree, and 99 Cents only, has decreased – from 67% of inspected cans in 2015 to 38% in a current study. However, 71 of 78 cans from Asia sold by independent dealers in California continue to contain BPA. These numbers were published by the non-profit Center for Environmental Health (CEH) in its current report, Kicking the Can. The organization also issued a press release on the study.

Since the beginning of the year, the agency responsible for risk assessment in California, the Office of Environmental Health Hazard Assessment (OEHHA), has published an online list of products containing BPA on its Proposition 65 Web site. Yet, the list displayed only 3 of the 71 cans that contained BPA.

Since May 2016, the Californian environmental law (California Proposition 65) has required notification of the possible risks of using BPA. However, no generally binding regulation exists about how to define the notification. Agency managers prefer to wait for the results of a larger study of BPA.

Pay attention to the safe use of your products. We are pleased to offer counsel and answer any questions at reach@kft.de.

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China: Companies Burdened by Complex Requirements

The intricacy and complexity of Chinese chemicals laws makes them almost impossible to manage, said a manager of Lubrizol, a U.S. chemicals company, at ChemCon Asia 2017. She stated that the provisions are often formulated ambiguously, the requirements are unclear, and the entire procedure is characterized by a tremendous amount of red tape.

She also observed that the various Chinese agencies that are responsible rarely communicate with each other, so that many specifications must be provided twice. For example, according to the Chinese chemicals law, “Regulations on the Safe Management of Hazardous Chemicals”(Decree 591), agency representatives often demand very detailed specifications.

We are familiar with the chemical compliance regulations in Asia. Please contact us at any time at sds@kft.de.

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Corporate Survey: New Registrations Take Precedence Over Updating REACH Documents

According to survey taken by Chemical Watch, leading manufacturers in the chemicals industry neglect regular updates of REACH documents and instead devote their resources to the registration of new substances, which must be completed by May 2018.

Chemical Watch asked nine corporate groups, among them BASF, Bayer, AkzoNobel, Evonik, and Lanxess, about their priorities in terms of updates and new registrations. For example, BASF has submitted about 2,000 updates. This figure can be compared to 1,500 new registrations, and more are on the way. Lanxess plans 600 new registrations, Evonik about 800, Bayer 400, and AkzoNobel 339.

Of course, all companies stated that they provide automatic notifications of important changes to substance information. Nevertheless, Volker Soballa, director of product stewardship at Evonik, admits that not all documents are updated regularly. Doing so would tie up too many resources and not improve the safety of people or the environment. Given that the registration period expires in May 2018, new registrations of substances have a higher priority, says Soballa. He also states that about 40% of the documents are updated and that a plan to update the rest will be developed after May 2018.

According to Article 22 of REACH, registrants must take the initiative to update their own registrations promptly based on pertinent new information and transmit the update to the agency.

The ECHA criticized the companies for a lack of cooperation, but the company managers countered the accusation of the ECHA by placing responsibility for the situation on the complex completeness check and the various data and format requirements of IUCLID.

We ensure the legal compliance of all your REACH documents. If you have questions, please contact us at reach@kft.de.

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EU Commission Forbids Additional CMR Substances in Cosmetics

The EU Commission has published the Draft of the Commission Regulation and will amend Annex II (Black List) of the Cosmetics Regulation to include nine CMR substances of Category 1 (known to be or suspected of being carcinogenic in humans):

  • Quaternium-15
  • Chloracetamide
  • Dichloromethane
  • Formaldehyde
  • Perboric acid and sodium perborates
  • Borates, tetraborates, and octaborates

The Commission’s Scientific Committee for Consumer Safety (SCCS) approved the use of three CMR substances of Category 2 (suspected of being carcinogenic in humans) in small concentrations and included them in Annex III:

  • Trimethylbenzoyl diphenylphosphine oxide (TCO) for professional use in artificial nail systems with a maximum concentration of 5%
  • Furfural at a maximum concentration of 0.001%
  • Polyaminopropyl biguanide (PHMB) at a maximum concentration of 0.1%, except in sprayable formulations

The Annexes take effect 20 days after their publication in the Official Journal.

We are pleased to advise you regarding issues related to the cosmetics regulation. You can reach us at cosmetic@kft.de.

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Turkish REACH Takes Effect on December 23, 2017

The Turkish Ministry of Environment and Urbanisation (MoEU) published the new Chemicals Law (KKDIK) (in Turkish) in the official gazette on June 23.

The new law succeeds at implementing the bulk of REACH. Substances may no longer be marketed without registration, as Yahya Kesimal, head of the chemicals division of MoEU told ChemicalWatch.

According to Kesimal, eight of ten Turkish companies have already registered their substances under EU REACH. He also says that providing the required translations into Turkish are not a problem for the companies.

Read more about this topic in our blog post, Turkish REACH to Arrive in Summer, where we report on a presentation given by our partner Melih Babayigit of CRAD.

Together with our Turkish partner CRAD we will support you if you operate in the Turkish market. Please contact us at sds@kft.de.

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Switzerland Updates Its Substances List

The list of new substances notified or registered in Switzerland was updated with 325 items in June. Switzerland updates the list each year in January and June.

New substances manufactured in or imported into Switzerland in a quantity greater than one ton must be registered with the notification authority before they are marketed. The requirement also applies to substances already registered with the EU. For detailed information, see the information provided by the Swiss central notification authority.

The Swiss Chemicals Ordinance was revised in 2015. Since then, it is called the Ordinance on Protection against Dangerous Substances and Preparations (Chemicals Ordinance: ChemO) of 5 June 2015 with registration number SR 813.11.

For the most part, Swiss law on chemicals corresponds to that of the EU. The Swiss Environmental Ministry has compiled a fact sheet that covers the differences (in German only).

If you have any questions about the legal compliance of your products, please contact us at reach@kft.de.

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ECHA: Titanium Dioxide Carcinogenic When Inhaled

The Risk Assessment Committee (RAC) of the ECHA has suggested that titanium dioxide be classified in hazard category 2 and sent its recommendation to the EU Commission, which must now decide on a regulatory response. A decision is expected in September. The recommendation means that classification of the substance in carcinogen category 1B and inclusion in the REACH candidate list, as proposed by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES), is no longer an option.

Nevertheless, the industry does not wish to accept the RAC’s decision. Robert Bird, chair of the Titanium Dioxide Manufacturers Association, says that there is no reason to classify the substance in this hazard category and that doing so would not serve to increase protection of human health or the environment.

The BDI published a similar criticism in a position paper (German only). The author, Dr. Mirjam Merz, emphasizes that so far, no relevant study has shown a connection between exposure to titanium dioxide and lung tumors. The decision of the RAC is primarily based on studies with rats, she says. The rats were exposed to a concentration of titanium dioxide dusts of up to 200 times the alveolar dust fraction permitted in the workplace. And, she adds, studies with rats cannot be applied to humans because their relevance for humans has not been proven.

The pigment industry in Germany is the primary customer of titanium dioxide, consuming 57% of production. In a press release (German only), the industry expressed shock at the classification. “Without an adequate scientific basis, one of the most important raw materials of our industry is unjustly being stigmatized,” says Dr. Martin Engelmann, managing director of the German Paint and Printing Inks Association (Verband der deutschen Lack- und Druckfarbenindustrie: VdL).

Does your work with titanium dioxide raise any questions about the marketability of your products? We’d be pleased to advise you. Just contact us at cosmetic@kft.de.

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