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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U.S. FDA Bans 19 Hazardous Chemicals from Soaps

The U.S. Food and Drug Administration (FDA) has forbidden manufacturers from selling soaps that contain specific active antibacterial ingredients to consumers. Some 19 substances are involved; manufacturers have one year to remove the products from the market and find substitutes for the banned active ingredients.

The American Cleaning Institute, a trade association, reacted cautiously. The FDA wants to see evidence that indicates the benefits of triclosan within one year. However, the substance can still be used in hand disinfectants used in hospitals and medical offices. According to the FDA, most hard and liquid soaps in the United States contain at least one of the forbidden ingredients. The most common are triclosan and triclocarban. The FDA stated that manufacturers have not yet provided the required proof that the substances are harmless to health and that they are more effective than traditional soaps. Korean researchers have studied the effects of soaps with and without triclosan and have not found any differences. They have published their results in the Journal of Antimicrobial Chemotherapy.

In their press release, the authorities at the FDA wrote that the ingredients are more harmful than beneficial. For example, animal experiments have shown the substances to have impaired muscle function and that they may also have a hormonal affect. The wide use of the ingredients for more than 30 years has already spread them throughout the environment. They have been used as ingredients in disinfectants, toothpastes, and soaps and have been used to treat mattress coverings, sport and performance textiles, shoes, and carpeting. According to the U.S. Centers for Disease Control and Prevention, the substances appear in the urine of three out of every four men and even in the umbilical cord blood of pregnant women.

As early as 2006, the German Federal Institute for Risk Assessment (BfR) (text in German only) called for limiting the use of triclosan to hospitals and medical practices or the chemical would foster the development of resistant bacteria.

According to the Biocide Regulation, triclosan can no longer be used in hygiene products after January of this year.

If you have any questions about triclosan and the effects of the FDA decision, please contact us at biocides@kft.de.

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Controversy Surrounding Company Size: EU Court Issues Judgements

In cases involving the ECHA and three Italian chemical companies, the European General Court issued three different judgements. In two cases, the court found for the plaintiffs (K Chimica and Crosfield), but found for the ECHA in another case (Marchi Industriale).

 The background of the legal controversy was the decision of the ECHA to classify the companies as large and thereby demand larger registration fees. The companies protested by filing a lawsuit.

 All three companies had registered several substances in 2010 and classified themselves as small and midsize companies. The ECHA then requested additional information and, based on that data, changed the initial classification from small and midsize to large companies.

 Missing information about the size of a company has created and continues to create legal conflicts. For a good overview of the topic, see our blog on Company Size as an Issue: The ECHA Offers Guidance.

 If you have questions about registration in the context of REACH, please contact us at any time at reach@kft.de.

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What You Should Know About the CLP Regulation

In August, the German Chemical Industry Association (Verband der Chemischen Industrie) published a brochure (available in German only), that contains updated and easily understood information on the Regulation on Classification, Labelling and Packaging of Substances and Mixtures (CLP). Among other points, it covers adoption of the Globally Harmonized System (GHS) in the European Union’s CLP, the importance of Annex VI (list of substances), classification and labeling according to Article 40, respectively 41 of the CLP, and notification to Poison Information Centers according to Article 45 of the CLP. The authors also describe how new classification and labeling affect downstream regulations and discuss the differences between European and international GHS. The document contains many useful links to additional information.

If you have questions that the brochure does not cover, please contact us at clp-info@kft.de.

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German Federal Institute for Risk Assessment Warns About Contaminants in Canned Fish

Canned fish preserved in oil contains comparatively high levels of cyclo-di-BADGE (CdB), an undesirable reaction product that is created during polymerization of BADGE (2,2-Bis(4-hydroxyphenyl)propanbis-(2,3-epoxypropyl)ether, CAS no. 1675-54-3) with bisphenol A (BPA) and of BPA with epichlorhydrin. That’s the finding of a statement (available in German only) of the German Federal Institute for Risk Assessment (BfR). Cans and tubes are coated with the resulting epoxy resin; the resin should prevent direct contact between the contents and the metal can.

However, it has long been known that CdB can migrate from the epoxy resin into food. As early as 2010, the BfR Commission reported on tests of canned fish that contained up to 2 mg cyclo-di-BADGE/kg in food. Because no experimental data on gene toxicity and subchronic toxicity exist, the BfR recommends the study of these question to base the evaluation of risk on a solid foundation. The agency is also advising consumers to avoid “above-average consumption” from such cans.

Ensure the safety of your products by keeping questionable substances away from food. If you have any questions, contact us about regulatory chemical compliance at reach@kft.de.

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South Korea to Approve New Biocide Law Soon

The South Korean Ministry of Environment (MoE) wants to advance the planning of a Biocides Law quickly. The urgency results from a scandal involving humidifier disinfectant made by Reckitt Benckiser. An ingredient in the sanitizer, polyhexamethylene guanidine (PHMG), was responsible for more than 100 deaths and numerous injuries a few years ago. The case has surfaced again because the company just officially apologized in May for the harm done.

The planned law will contain elements of the European Biocidal Product Regulation (EU) No. 528/2012, such as a list of permitted ingredients and the definition of rules to follow when handling articles.

According to the MoE, a list of 15 products already exists, including air fresheners and deodorants. Manufacturers and importers are now being asked to supply data on their products, including all ingredients, the purpose of their use, and possible risks and dangers. They are also to sign a declaration that they agree to the publication of the data.

In the next step, planned for 2017, data on biocidal products contained in industrial products, electrical appliances, and packaging is to be collected and prepared for legal regulation.

We help and advise companies that have business relationships in Asia. If you have any questions, please contact us at biocides@kft.de.

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Registration Dossiers: ECHA Calls for Regular Updates

In their latest ECHA Report, the authors criticize the poor quality of registration dossiers. Only one of every three documents reflects the current state of information on the use of and exposure to specific substances. Updates usually occur only under pressure from authorities.

In a conversation with the online portal ChemicalWatch, the deputy executive director of the ECHA, Jukka Malm, argued for a solution that does not impose any new burdens on companies, but simply clarifies existing law.

In fact, Article 22 of Reach obligates registrants to update their dossiers upon their own initiative and “without undue delay“ when new information becomes available and to transmit the revised dossier to the agency. Malm believes it would be better to define a concrete period of time rather than use the current vague formulation.

Nevertheless, the ECHA continues to appeal to the initiative of companies. According to Malm, firms should view their obligation to update dossiers as an opportunity, not a burden. He knows of cases in which a substance was considered for possible inclusion in the authorisation list. Yet, the ECHA dropped the require because more up-to-date data indicated limited usage of the substance.

Do you need any support with the registration of substances? Please contact us under reach@kft.de.

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U.S. Discounter Walmart Bans Harmful Substances from Its Products

Walmart has compiled a list of high priority chemicals (HPC) that the discounter wants to ban from its products. The substances include toluene, dibutyl phthalate (DBP), diethyl phthalate (DEP), nonylphenol exthoxylates (NPE, including nine CAS numbers), formaldehyde, butylparaben, propylparaben, and triclosan. If the FDA allows, however, triclosan can be used as an active ingredient that provides therapeutic benefit.

In selecting the substances, Walmart used official lists of harmful substances, the quantities used, the burden placed on the consumer, and new regulations that are being planned for the substances.

Walmart began its environmental program three years ago with the support of the Environmental Defense Fund (EDF). The company was able to reduce the amount of these substances by up to 95% (by weight) in most products, including health and beauty aids, household cleaning agents, and baby products. That’s “over 11,500 tons – 23 million pounds – of chemicals out of so much product in less than 24 months,” says Michelle Mauthe Harvey of the EDF. The goal is to remove all the substances completely from the products. Some 90,000 products from 700 vendors are involved.

In particular, products that come into contact with the skin must be safe. Companies that substitute safe substances for risky ones gain a long-term competitive advantage. If you have any questions about regulatory chemical compliance, we are pleased to provide answers and advice at cosmetic@kft.de.

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