KFT Goes to Hollywood

People say that a picture says a thousand words. How much more do movies say? But how can a film cover the complex topic of regulatory chemical compliance? And how could anyone develop a meaningful plot based on it?

Regulatory chemical compliance appeals to our desire for safety and security, so it also deals with trust. Customers and users want trustworthiness and transparency. They want to be sure that a product actually contains what the label indicates and that the label indicates what a product actually contains– and they want to do both seamlessly. Those who take that to heart will have fans on their side. In short: Brands that want to be seen as likeable and reputable should at least do what the law requires.

But enough with the words: Let the pictures speak!

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China: List of Toxic Chemicals Modified

In the future, the Chinese Ministry of Environmental Protection (MEP) will align itself with international conventions on the import and export of chemicals. The agreements involved include the Stockholm Convention, the Minamata Convention, and the Rotterdam Convention. The new approach took effect this January.

The new policy replaces the previous list of about 150 strictly regulated chemicals with a new list (only in Chinese). ChemicalWatch provides an English translation. The new list not only contains chemicals subject to import and export restrictions, but also subject to restricted use.

All 35 chemicals on the list are included in one of the conventions. Importers and exporters of such
substances must apply to the MEP for a release from customs.

In particular, we would like to invite you to our Chemical Compliance Day on April 12, where we have been able to schedule a speaker who is an official representative of a Chinese governmental agency. You can learn firsthand the Chinese requirements for safety data sheets, the registration of chemicals, and so on.

For questions about labeling requirements in China, the creation of safety data sheets, or the registration of new chemicals please contact us at sds@kft.de.

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REACH 2018: Extension in Case of Missing Data

Companies that must register their chemicals by May 31, 2018 but that do not yet have all the test results they need for the dossier, should notify the ECHA of the situation. But an exception for such cases involves some preconditions. For example, if the data required by Annexes VII and VIII is missing, the companies must provide a justification for the delay and submit a copy of their contract with the testing laboratory – which must be dated before March 31. They must also let the ECHA know when they expect the results. You can find this information and more details in the notice issued by the Directors’ Contact Group (DCG) of the ECHA.

If the registration dossier contains all the data (physicochemical, toxicological and ecotoxicological), the document passes the completeness check. If it does not, the ECHA will grant an extension if a company provides notification before May 24, 2018.

The Stakeholders Day held in Helsinki at the end of January covered for the first time how to deal in exceptional cases. According to a report by ChemicalWatch, the announcement by the ECHA surprised participants in the meeting.

For example, Céline Coste, who is responsible for chemical registration at Solvay said that she did not know that the ECHA was to be notified of delays. She is hardly the only participant affected by the news.

Mercedes Vinas, director of dossier submission, admitted that more companies than expected will have to apply for an exception. The ECHA does not have an emergency plan for this situation. In her presentation, Vinas provided the current numbers for REACH 2018.

According to Vinas, the ECHA had received some 15,000 registrations for about 6,500 chemicals (in quantities less than 100 tons per year). 4,200 of the chemicals were registered for the first time. Some 801 companies registered a chemical for the first time in 2017, and 16% of them are small and midsize enterprises (SMEs). She also provided numbers on registrations outside the EU. Some 43% of those registrations came from importers and 28% from Only Representatives.

You can download all the presentations given at the Stakeholders Days here.

Do you have any questions about REACH 2018? If so, please contact us at reach@kft.de.

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Brexit: What Legal Experts Recommend

With its more than 1,400 environmental law experts, the leading membership organization for environmental law in the United Kingdom (UK Environmental Law Association) has taken a clear position in regard Brexit. It recommends that the government continue to adhere to the standards established in EU environmental law. In its report, Brexit and Environmental Law, the authors show how important cooperation with organizations like the ECHA is and illustrate the results of a failure in case cooperation is not legally possible.

Despite the clear position of the legal experts, some voices in the government favor Great Britain taking its own path. Above all, Michael Gove, Secretary of State for Environment, Food and Rural Affairs, sees advantages in that approach. He gave an example in a report of the Environmental Audit Committee (EAC): Chemicals prohibited in the EU could be manufactured in Great Britain and then sold on the U.S. Market (see page18)

The unsure legal situation has moved the Only Representative Organisation (ORO) to create a plan and publish a document with recommendations for Only Representatives and importers. The ORO plays out two possible scenarios and offers corresponding alternatives. The first would apply in the event of a hard Brexit: Existing registrations would then be invalid as of March 2019. The second would apply if an agreement is reached within the negotiation period, and Great-Britain creates its own law that is similar to REACH.

The German Chemical Industry Association provides a current overview (November 2017, only in German) of the potential effects of Brexit on the chemical and pharmaceutical industries.

Do you want any questions about regulations pertaining to sole representative of about Brexit? If so, please contact us at reach@kft.de.

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Big Data Helps Limit Animal Experiments

How Big Data revolutionizes toxicology and how risk assessments could be made safer even without animal experiments were discussed by scientists at the Alternatives and Animal Use in the Life Sciences conference last year in Seattle. The results have now been published in a highlight report.

As a rule, toxicological studies are to be performed according to the 3R Principle (replacement, reduction, and refinement). In other words, animal experiments should be avoided when possible or kept to a minimum. The animals should be affected as little as possible.

The authors write that access to toxicological data that enables a serious risk assessment continues to be difficult. To be able to read the required information from the data, scientists need high-quality, basic data. The technology solutions that capture, store, and present data should be standardized. Furthermore, the authors urge the scientific community to increased sharing the data. Risks can be assessed reliably only when all the available data is, in fact, available.

The authors also argue for better training of toxicologists in terms of the use of Big Data. In the future, they state, future studies of toxicity determination must focus less on the toxicological endpoint and more on the mode of action.

As part of registration, companies must also provide toxicological and ecotoxicological data. The scope of the data depends on the quantity of the chemical to be registered. Annexes III, VII, VIII, IX, and X of REACH Regulation provide information on the specific requirements. We are pleased to provide support if you have any questions. Please contact us at reach@kft.de.

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China Published List of Priority Control Chemicals

At the end of December, the Ministry of Environmental Protection (MEP) of the People’s Republic of China published a list of chemicals that have special legal controls. The MEP also issued a
notification (only in Chinese) on the subject. The list contains 22 chemicals that are especially
hazardous to human health and the environment. They also accumulate significantly in organisms.

The chemicals involved include:

  • 1,2,4-trichlorobenzene
  • 1,3-butadiene
  • 5-tert-butyl-2,4,6-trinitro-m-xylene (xylene musk)
  • n,n’-bis(methylphenyl)-1,4-benzenediamine
  • Short-chain chlorinated paraffins (SCCPs)
  • Dichloromethane
  • Cadmium and cadmium compounds
  • Mercury and mercury compounds
  • Formaldehyde
  • Hexavalent chromium compound
  • Hexachloro-1,3-cyclopentadiene
  • Hexabromocyclododecane
  • Naphthalene
  • Lead compounds
  • Perfluorooctanesulfonic acid (PFOS) and its salts and PFOSF
  • Nonylphenol and nonylphenol polyoxyethylene ether
  • Trichloromethane
  • Trichlorethylene
  • Arsenic and arsenic compounds;
  • Decabromodiphenyl ether (DecaBDE)
  • Perchlorethylene
  • Acetaldehyde

The use of these chemicals is regulated by various Chinese laws, including:

We would also like to inform you about and invite you to our Chemical Compliance Day on April 12. A representative of a Chinese agency will provide information on legal requirements in China. You can submit questions ahead of time at academy@kft.de, if you’d like.

If you have questions about classification obligations in China, creation of safety data sheets, or registration of new chemicals, please contact us at sds@kft.de.




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REACH 2018 and the Future of SIEFs

REACH provides that each SIEF (Substance Information Exchange Forum) shall be operational until June 1, 2018. The law doesn’t say anything beyond the period after June. Of course, the ECHA will continue to request data on chemicals, and dossiers must be updated after the deadline. A process must also exist to guarantee how to distribute costs among the registrants.

According to a report issued by ChemicalWatch, the ECHA is actively working with the EC
Commission to create a platform that enables companies to meet their REACH obligations
after the deadline.

The first SIEFs were established more than ten years ago, at the beginning of REACH
registrations. They were intended to force information exchange among companies about available studies to avoid animal testing and to come to an agreement regarding the classification of a substance. A SIEF exists for many chemicals. As a result, the registration phases have resulted in the creation of ever more SIEFs, sometimes with as many as 1,000 members.

The ECHA fears that after the deadline, arguments about a fair distribution of data could become more intense. The Regulation on Data-Sharing issued in January 2016 should help clarify matters. Please read our blog news “Regulation on Data-Sharing Takes Effect”. A common platform for communications is urgently needed, given the announcement by the new ECHA Director, Björn Hansen, that updating the data and the dossiers are among his top priorities.

Representatives of the European Chemical Industry Council (CEFIC) welcomed the work of the ECHA on a continuance of the SIEFs. Nonetheless, competitive provisions must be agreed upon and assurances made to ensure that the only data shared is assigned to a specific regulatory purpose.

We have supported companies with registrations in the context of SIEF for many years. If you have any questions, please contact us at reach@kft.de.

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Nanomaterials Remain a Safety Risk

According to the ECHA, nanomaterials remain a black box. Regulatory agencies find it difficult to check the potential hazards that arise from nanomaterials because the data required to prove their harmlessness continues to be unavailable. That’s the conclusion reached by members of the ECHA Management Board at their meeting in mid-December 2017. They see dwindling trust in the market for these materials and urge the EC Commission to act.

The authors also lament the laws that bind the hands of agencies and forbid them to demand the necessary data from companies. On the contrary, they are limited to the data that companies provide.

In the future, the ECHA will therefore increase its collaboration with individual countries and OECD test guidelines. The OECD recently updated its guidelines on chemical toxicity (in German) and the dispersion stability of nanomaterials.

Meaningful data is undoubtedly needed to estimate the dangers correctly. In January, scientists at the West Virginia University School of Medicine released the results of a study. They discovered that pregnant rats exposed to titanium dioxide aerosols experienced changes in fetal tissue. The authors argue that long-term human exposure to such nanomaterials could lead to similar damage.

The team selected titanium dioxide because it is the most widely spread nanomaterial. Last year, the Risk Assessment Committee (RAC) suggested a harmonized classification of Category 2, carcinogenic when inhaled.

Do you deal with nanomaterials and have any questions? Please contact us at cosmetic@kft.de.

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