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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REACH Regulation: 12 Substances Added to Annex XIV

In December, representatives of the member states of the EU will vote on adding 12 substances to Annex XIV. The member states already have drafts for the revised Regulation and the Annex. The new Annex classifies 8 of the 12 substances as Category 1 B, toxic for reproduction:

  • 1-bromopropane (n-propyl bromide)
  • Diisopentylphthalate
  • 1,2-benzenedicarboxylic acid di-C6-8-branched alkyl esters C7-rich
  • 1,2-benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters
  • 1,2-benzenedicarboxylic acid, dipentylester, branched and linear
  • Bis(2-methoxyethyl) phthalate
  • Dipentylphthalate
  • N-pentyl-isopentylphthalate

Two substances are carcinogenic (Category 1B) and have persistent, bioaccumulative, and/or toxic (PBT) and very persistent and very bioaccumulative vPvB properties:

  • Anthracene oil
  • pitch, coal tar, high temperature

Two substances have endocrine-disrupting properties:

  • 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated
  • 4-nonylphenol, branched and linear, ethoxylated

Once the substances are listed in Annex XIV of the REACH Regulation, they must be registered. Unless permission is granted for a specific use or an exception is granted, the substances may not be on the market after the sunset date. Inclusion of the substances in Annex XIV should minimize the presence of the substance in the environment as much as possible and force companies to find alternatives.
The EU Commission has observed a moratorium on adding substances to Annex XIV. It wanted to give the ECHA and national agencies time to simplify and accelerate the approval process for the 31 substances already on the list. According to various organizations, the moratorium is groundless. As early as May, the organizations urged an end to the moratorium in a letter. The proposed revision of the law is the response of the EU Commission to the request.

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Cosmetics Regulation Conflicts with the CLP Regulation

Substances that the CLP Regulation classifies as carcinogenic, mutagenic, or reprotoxic (CMR) may, under certain conditions, still be contained in cosmetics. The EU Commission made that decision at the most recent meeting of the working group for cosmetics. The crux of the issue is that some requirements of the Cosmetics Regulation contradict requirements of the CLP Regulation. Accordingly, the EU Commission is working under pressure to harmonize the regulations.
The most recent issue is once again Article 15 of the Cosmetics Regulation. The article forbids use of CMR substances classified as Category 1 (proven carcinogenic effects in humans) and Category 2 (proven carcinogenic effects in animals; suspected effects in humans). However, exceptions exist, as the members of the group emphasized at their meeting. According to the exceptions, CMR substances of Category 2 can continue to be used in cosmetics when the members of the Scientific Committee for Consumer Safety (SCCS) of the EU Commission consider them safe. Additional criteria apply to the use of substances of Category 1 (see Article 15).
Some countries, including Denmark, regard this interpretation as too broad. They demand a general prohibition of substances like the preservative polyaminopropyl biguanide (PAPB). Yet representatives of the cosmetics industry insist on the law currently in force and request that the EU Commission harmonize the contents of both regulations to create legal certainty for all concerned.
In his statement, the Commission made it clear that the CLP regulation does not replace the EU Cosmetics Regulation. A complete ban of cosmetics ingredients has to be established in the Annex of the Cosmetics Regulation.
Our services help ensure the chemical compliance and legal security of your products. Please contact us at cosmetic@kft.de. We would also like to remind you of our seminar on European Cosmetics Regulation 1223/2009 (German only) on November 16.

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ECHA Publishes List of Lead Registrants

The European Chemicals Agency (ECHA) has published a list containing the names of lead registrants on its Web site. The leaders of the ECHA want to make it easier for potential registrants to contact the representatives of companies that are already registered. They also want to promote an accelerated registration process, given that the notification period for REACH expires in May 2018.

The list includes about 7,000 substances that it has collected as part of all registration steps. Up to now, the list covers information only on substances that were preregistered by the end of 2008. The ECHA has announced that it intends to update the list with about 1,300 additional substances by the end of this year.

Current statistics (as of September 23) indicate 6,766 registrations of 3,510 substances. Large enterprises have completed some 85% of the registrations; small and midsize companies have completed only 15% of them.

Look for “REACH 2018” in our blog archive from May to June of this year for a number of helpful hints about what you should note during a registration. If you have any questions, please contact us at any time at reach@kft.de.

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Poison Information Centers: EU Harmonizes Product-Notification and Transfer Formats

According to Article 45 of the CLP Regulation, manufacturers, market launchers, and distributors must notify the appropriate national agencies of the formulations and contents of hazardous chemical mixtures, including laundry and cleaning supplies. They must also provide the data to poison information centers so that the centers can provide specific advice quickly in the event of an accident. Up to now, each country has had a different notification procedure. As a result, companies that operate in multiple EU countries face higher costs because they have to format the same information multiple times to meet the requirements of each country.

And that’s why the EU wants to implement a uniform solution for all its member states. Authorities estimate that such a solution would save manufacturers and importers a total of €550 million Euros and strengthen consumer protection. The CLP Regulation is now being amended (see the draft) to revise Annex VIII. The revision will take effect on January 1, 2020 and initially apply to hazardous mixtures intended for consumer use. As of January 1, 2021, it will apply to commercial hazardous mixtures; as of January 1, 2014, it will apply to hazardous mixtures intended for industrial use.

Each country determines its receiving body for product information. The EU offers a contact list for all European countries on its Web site. In Germany, the Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung: BfR) fulfills this role; it stores all product data in a poison information database. When an emergency occurs, the responding doctors in a poison information center can access the data and inform on-site first responders about the necessary countermeasures.

The exact changes involved in the harmonization are listed in Annex VIII (see above) of the CLP Regulation. For example, labels or containers will have to display a unique formula identifier (UFI), an alphanumeric code that enables unambiguous identification of products. The ECHA provides additional information (new data format, tools, guidelines) on its Web site.

For comprehensive information about this topic, consider the Seventh Annual BfR User Conference on Product Notifications on November 15 in the auditorium in Berlin-Marienfelde.

At KFT, we offer companies an emergency number service through our partners Chemtrec and Giftinformationszentrum Nord (GIZ). We would be pleased to provide you with personal information about the details of the service. Please contact us under sds@kft.de.

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Swedish Environmental Agency Finds Banned Substances in Plastic Products

During a random check, authorities at the Swedish Chemicals Agency (KEMI) found long-forbidden substances in common household products. They examined 160 plastic articles, including bathing and gardening supplies, work gloves, bags, and sporting goods. Some 38 articles contained phthalates, lead, cadmium, dimethylformamide, methylacetamide, and, most commonly, chlorinated paraffins, which are used as plasticizers and flame retardants. In their report (in Swedish, with a summary in English), the authors write that 14 of the items studied showed a concentration greater than the allowable threshold.

After the results were made public, some companies voluntarily stopped selling the products. The Agency issued a ban in two cases and referred 20 cases to prosecutors.

Protect your products and their marketability. We can help. Contact us at reach@kft.de.

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EU Commission Enacts Alternative Testing Methods

The EU Commission has amended Annex VII of the REACH Regulation. According to the change, in vitro testing is to replace in vivo (animal) testing whenever possible in testing the effectiveness of substances used for skin sensitization.

REACH Regulation (EC) No. 1907/2006 has so far supported only in vivo experiments. However, such testing no longer corresponds to the state of science. Since the original Regulation was written, in chemico and in vitro testing methods have been internationally recognized by the European Union Reference Laboratory for Alternatives to Animal Testing (EURL-ECVAM) and the Organization for Economic Co-Operation and Development (OECD).

Furthermore, sensitization testing will no longer be required for substances that are:

  • Classified as skin corrosion (category 1)
  • Classified as a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5)
  • Spontaneously flammable in air or in contact with water or moisture at room temperature.

A good overview can be found in the Report from the Commission to the European Parliament and the Council on the development, validation, and legal acceptance of methods alternative to animal testing in the field of cosmetics (2013-2015).

We are happy to answer any questions you might have at cosmetic@kft.de.

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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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