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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EU Publishes 11th ATP for the CLP Regulation

The EU Commission has issued Regulation (EU) 2018/669, the eleventh amendment of the CLP Regulation (EC) No. 1272/2008, an adaptation to technical and scientific progress (ATP). The new regulation takes
effect on May 24. The transition period will end on December 1, 2019. It gives suppliers an opportunity to adjust the labeling and packaging of chemicals and mixtures appropriately.

The amendment affects Table 3, “list of harmonized classification and labelling of hazardous substances” in Part 3 of Annex VI of the CLP Regulation. Thus, the chemical names are available in the individual languages of the member states. The chemical names on the label and in the individual parts of the safety data sheets will have to be written in the respective national language.

The amendment does not add any new substances, and the classification of substances remains unchanged.

The EU published the tenth amendment in May 2017. Please see our blog entry, CLP: Tenth Adaptation to Technical and Scientific Progress Published.

If you have any questions on this topic, please contact us at clp-info@kft.de.

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WHO: Styrene Probably Carcinogenic

The International Agency for Research on Cancer (IARC), an agency of the World Health Organization (WHO) headquartered in Lyon, France, has classified styrene, styrene-6,8-oxide, and quinoline as probably carcinogenic (2A). The agency had previously classified styrene as possibly carcinogenic (2B). The higher classification has consequences for entities and countries that use the IARC as a standard for regulations, as is the case in California.

The new classification is based on a study that appeared in April in the journal The Lancet Oncology. According to the study, workers who manufacture reinforced plastics and thereby come into contact with styrene are more likely to suffer from lymphohaematopoietic malignancies. The authors of the study
therefore regard it as valid proof that exposure to styrene leads to this type of cancer. Nevertheless, they admit that the influence of confounding, bias, or chance cannot be completely excluded.

However, the knowledge gained to date from animal experiments is unambiguous. Researchers conclude that the mechanisms in animals and humans are the same and that the substance has genotoxic effects.

According to the journal Procedia Engineering, about 20 million tons of styrene were produced in 2012. More than half of that amount is processed into polystyrene. Quinoline is an ingredient in the manufacture of medicine and dyes. Styrene oxide is used to manufacture epoxy resins.

The American Chemistry Council (ACC) criticized the classification of styrene. It is incomprehensible because the study is based on outdated rules that are now being revised by experts, says Cal Dooley, president and CEO of the ACC. He also questions the timing of the publication, given that the IARC will have a new director at the beginning of 2019, who may well focus on completely different questions.

We are always pleased to advise you on the marketability of your products. You can reach us at reach@kft.de.


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Textiles: New Restrictions on CMR Substances

The REACH rules committee of the EU Commission has approved further restrictions on 33 carcinogenic, mutagenic, and reprotoxic (CMR) substances in textiles, clothing, and footwear. The draft now goes to the European Parliament and Council for final approval. The EU Commission is expected to publish the regulation in the Official Journal in Q3 2018. After a transition phase of 24 months, the regulation will go into full effect.

The 33 CMR substances include cadmium, chrome, arsenic, lead (and its compounds), various polycyclic aromatic hydrocarbons, formaldehyde, phthalates, the solvent dimethylacetamide, and certain dyes. The substances are present in textiles during the production process or are added to them to prevent wrinkling or shrinkage. You can find the complete list of restricted substances in the draft of the annex of the planned regulation.

The following products are exempted from the regulation:

  • Personal protective equipment as defined in EU Regulation 2016/425 in relation to clothing, accessories, textiles, or shoes
  • Medicinal products as defined in EU Regulation 2017/745 in relation to clothing, accessories, textiles, or shoes
  • Clothing, accessories, textiles, or shoes or parts of clothing, accessories, textiles, or shoes made
    exclusively from natural leather, fur, or hides
  • Non-textile fasteners and decorative elements
  • Second-hand clothing, accessories, and textiles other than clothing and shoes

In 2015, the EU Commission published a preliminary list of 286 CMR substances that were to be restricted. Environmental groups and the European Consumer Organization (BEUC) feel that the new regulation does not go far enough. An association of environmental groups has written a letter to the REACH Committee calling for a prohibition of all CRM substances. Monique Goyens, general director of BEUC, was equally disappointed. “We are glad that the EU is taking the bull by the horns, and that some harmful substances will disappear from the clothes we wear and the bedsheets we sleep in. But the EU missed an opportunity to protect consumers better,” she said.

We are pleased to advise you about the legal implications of the new regulation for your products. Please contact us at reach@kft.de.

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Cosmetics: Consumer Associations Advises Against Purchases from a U.S. Online Store

The Danish Association of Cosmetics and Detergents (SPT) has issued a warning about products from Wish.com, an online store based in the United States, and advised consumers not to purchase any cosmetics there. The reason is a study undertaken as part of the Think Chemicals initiative. Scientists bought and inspected about 39 different cosmetics from the site. The sobering conclusion? The labels on more than half of the products did not comply with the labeling requirements of the EU Cosmetics Regulation. An indication of the ingredients was missing for 21 of the products. Although a well-known face cream listed its ingredients, they included two allergenic preservatives, methylisothiazolinone (MIT) and methylchloroisothiazolinone (MCI), both of which are prohibited in the EU. According to SPT, many of the products involved come from China.

The EU Cosmetics Regulation (EC Regulation No. 1223/2009 and No. 2016/1198) has prohibited MIT in leave-on cosmetics products (like face lotions and creams) since February 2017. Even stronger threshold values have applied to rinse-off cosmetics and body care products since April 27 of this year. The EU Cosmetics Regulation (EC Regulation No. 1223/2009 and No. 2017/1224) requires with immediate effect that MIT be limited in a ready-to-use preparation of cosmetics only up to a concentration of 0.0015%.

MCI used in mixtures with MIT (3:1) is permitted as a biocide only for defined types of products according to Implementing Regulation (EU) 2016/131.

According to the Netherlands National Institute for Public Health and the Environment (RIVM), isothiazolinone (21% of cases) and fragrances (46% of cases) cause the most allergies in cosmetics. For more information, see our blog entry.

Ensure the legal security of your products as soon as possible. Contact us at cosmetic@kft.de.

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ECHA: Online Ads for Many Products are Not Legally Compliant

As part of an enforcement project, the ECHA examined more than 1,300 online advertisements for chemical mixtures, including cleaning products, paints, and pesticides. The result? More than 80% of the products did not meet the requirement of the CLP Regulation. About 90% of the labels had no hazard warnings whatsoever. But the most surprising fact is that almost all the Web sites examined belonged to professional suppliers.

Concretely, the companies violated Article 48, Paragraph 2 of the CLP Regulation: “Any advertisement for a mixture classified as hazardous or covered by Article 25(6) which allows a member of the general public to conclude a contract for purchase without first having sight of the label shall mention the type or types of hazard indicated on the label.”

As the ECHA Report indicates, agencies from 15 EU countries participated in the project. The inspectors focused on compliance with Article 48, Paragraph 2 and with Article 17, Paragraph 2, which states that the hazard warning must be present in the local language.

The inspections took place between January and August of last year, mostly in Germany (508) and the Czech Republic (361). Fines were imposed in 208 cases, and a few cases even resulted in possible criminal charges.

Given the high number of issues, the ECHA has promised appropriate recommendations. The first applies to associations in the countries involved, which should publish complaint samples during campaigns to inform companies of the requirements. The second applies to the EU, which should formulate Article 48 more clearly and publish the appropriate regulations. The need for such a move is evident not only in this study, but also in a Norwegian study of November 2017 (please see our blog).

The ECHA has also issued a press release on the results of the study.

We are pleased to support you in all your concerns related to the CLP Regulation. Please contact us at kft@clp-info.de.

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Sweden: One of Ten Products Labeled Incorrectly

The Swedish chemicals agency KEMI, examined about 24,000 products that contain hazardous chemicals. Some 2,600 of the products, most of them cleaning products, were found to be labeled incorrectly. In three of every four cases, the labels did not comply with the requirements of the CLP regulation. More than half of the companies studied had at least one incorrectly labeled product.
The following additional errors were also found:
15% of the products did not carry labels printed in Swedish.
8% of the products did not feature warnings for people with visual difficulties.
3% of the products did not have childproof closures.

Most of the faulty products were taken off the market immediately. More-serious cases were referred to legal authorities, and in many cases, environmental crimes are suspected. KEMI has issued a press release and an inspection report (both in Swedish only).

As if June 1, 2017, the requirements of the CLP Regulation (Regulation No. 1272/2008) have been in full force. Even hazardous mixtures like household cleaners, solvents, or construction chemicals must carry the appropriate labels. Among other requirements, the labels must identify the supplier. They must also indicate the type and quantity of the substance and/or mixture involved along with a hazard pictogram and safety instructions.

See this info sheet (German only) for a good overview.

If you have any questions, please contact us at clp-info@kft.de.

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EU Amends Article 9 of the Waste Framework Directive

The EU parliament has approved an amendment of Article 9 of the Waste Framework Directive. The draft will now be submitted to the EU Council for formal approval. The change to the law is likely to take effect in July.

According to the reformulated Article 9 of the Waste Framework Directive, manufacturers and importers must notify the ECHA of all SVHCs contained in their products. For its part, the ECHA is obligated to make a database available for submission of the information within 18 months after the law takes effect. The database is to be accessible to operators of waste disposal facilities and, upon request, to consumers.

The goal of the revision is to remove SVHC from the materials cycle in the mid to long term. This measure, however, is only part of a complete circular economy package with which the EU stimulate the circular economy.

According to the ECHA, the database will create the foundation for fair competition, given that products imported into the EU must follow the same notification requirements as those manufactured in the EU.

For an understanding of the relationship between REACH and the Waste Framework Directive, see REACH und Recycling (German only), published by the Federal Institute of Occupational Safety and Health. For a good overview of the EU’s circular economy see the response (German only) of the German government to a brief inquiry raised by BÜNDNIS 90/DIE GRÜNEN.

We can support your compliance with all legal requirements when dealing with products containing substances that can be harmful to health. Please contact us at reach@kft.de.


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