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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Deadline for Phase-In Substances Is Approaching

By June 1, 2017, all phase-in substances (Link in deutsch) ranging from 1 to 100 tons must be preregistered. Preregistration ensures that a company can participate in a joint registration until June 1, 2018 without the need for a preliminary application. The marketability of the substance is allowed up to this date.

If a company misses the preregistration period, the marketability of the substance in question can be maintained only with an inquiry. The identity of the substance is checked as part of the inquiry. It can take several months to process the preliminary application and the registration. During that time, the substance cannot be marketed. A company can import or manufacture the substance only after it has received a registration.

Preregistration is a purely formal act. The ECHA provides the required formats free of charge. Nevertheless, all manufacturers and importers must perform the preregistration of the substance themselves.

“We recommend that every company have its supplies of existing substances inspected and preregister all substances present in a quantity less than 100 tons so that they can avoid import prohibitions,” says REACH expert Dr. Nicolas Heidrich, KFT.

We would be pleased to support you during preregistration of your substances. Please contact us at reach@kft.de.

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Titanium Dioxide in the Crosshairs Again

Scientists at the French Agricultural Research Institute (Institut National de la Recherche Agronomique: INRA) found that titanium dioxide (E171) can cause colorectal cancer when used as a food additive. The scientists evaluated tests taken when the animals were given food that contained titanium dioxide for short periods and longer times – and in the concentration typical of food appropriate for humans.

The researchers proved that the titanium dioxide particles passed through the intestinal wall and could reach the liver. They also found the particles in the lymph nodes of the small intestine, where they could weaken the immune system.

For E171, the particle size of titanium dioxide ranges between 30 and 400 nanometers. About a third of the particles have a diameter of less than 100 nanometers. Daily ingestion of feed containing #171 had a toxic effect on the animals, concluded the scientists.

By the end of 2015, the French Agency for Food, Environmental, and Occupational Health & Safety (ANSES) had suggested harmonized categorization of titanium dioxide into category 1B. That would be a major step on the way to including it the list of substances of very high concern (SVHC). The substance would also be forbidden in consumer products.

The Risk Assessment Committee (RAC) of the ECHA wants to study the request of the French agency to evaluate all existing studies and make a decision by the end of the year.

Do you deal with products that contain titanium dioxide or do you have questions about the marketability of your products? If so, please contact us at cosmetic@kft.de.

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France: Reporting Requirement for Hazardous Mixtures and Biocides

New reporting requirements took effect on January 1, 2017 for companies that export hazardous mixtures or biocides to France. The Institut National de Recherche et de Sécurité (INRS) is the recipient of the reports.

In addition to the previously required hazard notifications, the new rule mandates the following notifications:

  • Sensitization of the respiratory tract, category 1 (H334)
  • Sensitization of the skin, category 1 (H317)
  • Carcinogenicity, category 2 (H351)
  • Germ cell mutagenicity, category 2 (H341)
  • Reproductive toxicity, category 2 (H361)

Additional hazard warnings have been announced for 2019 and 2022. Reporting requirements have been in force for biocides since January 2017. Companies affected by the requirements can use the IT tool provided by the INRS: Déclaration Synapse. It requires a signature.

The background of the requirement is Article 45 of the CLP Regulation. It mandates that manufacturers, importers, and marketers report the recipe and content of hazardous chemical mixtures, biocides, detergents, and cleaning products to the national agencies that are responsible, the INRS in this case. The agencies then provide the data to poison information centers that physicians can query specifically in emergency situations. Because the reporting process differs in every country, it’s advisable for companies that do business in multiple EU countries to maintain an overview of the various requirements that apply.

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Turkish REACH: Closing Consultation and Corporate Concerns

Until the end of January, representatives of affected industries can comment on the current draft of the planned Turkish chemicals law (KKDIK), before the Ministry of Environment and Urbanisation(MoEU) publishes the law at the end of March. The current registration deadline is December 31, 2022; preregistration should be complete by the end of 2019.

Industry objections primarily involve the costs of registration, which many of the mostly small and midsize companies affected by the law are almost impossible to pay. That’s why the industry representatives have asked the ministry to support the companies appropriately.

The annexes to the regulation are also unclear. Right now, the substances in Annex 17, which have limitations, agree with the list given in EU REACH, but the list has not yet been updated. However, no consensus yet exists about of the substances given in Annex 14 that are subject to approval.

The planned Annex 18, which does not appear in the EU regulation, might be the Achilles’ tendon of KKDIK. The annex defines the roles and qualifications that an expert on processing the approvals and notifications must absolutely have. Industry representatives fear that only very few people can fill the required profile, which requires 10 years of professional experience. The resulting personnel bottleneck means that the processing times have been lengthened. Hiring of foreign experts might be a possible solution.

Do you operate in the Turkish market? If so, please attend our Customer Day on May 11, 2017 (only in German). The new chemicals law in Turkey will be the topic. The CEO of our Turkish partner CRAD, Melih Babayigit, will offer first-hand information. Please contact us at sds@kft.de.

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Trump Places Gag Order on the EPA

The Trump administration has issued a directive that closes communication between the EPA and the public until the EPA director, Scott Pruitt, takes office. The directive also postpones the effective date of 30 regulations from February 10 to March 21, 2017. One such regulation sets the threshold values for the evaporation of formaldehyde from wood composites. Nevertheless, the reporting rule that the EPA issued for nanomaterials will go into effect as planned.

The gag order also applies to scientists at the U.S. Department of Agriculture and U.S. Department of Health and Human Services. A limited block on the release of information is common during a change of administration. However, representatives of environmental organizations fear that scientists will face future limitations about informing citizens about risks and protecting them from possible health hazards.

Andrew Rosenberg, director of the Center for Science and Democracy at the Union of Concerned Scientists criticized the measures as disproportionate in a press release. “Scientists,” he says, “carry out research in support of policies that protect our . . . safety . . . it makes no sense to put up walls between them and the public.”

We, however, ensure transparency for chemical compliance and offer support in word and deed so that you can market your products safely. Please contact us under reach@kft.de.

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U.S. EPA Issues Reporting Rule for Nanomaterials

On January 12, 2017, the U.S. Environmental Protection Agency (EPA) issued a reporting and recordkeeping rule into the Federal Register of the United States. The rule, as defined in its paragraph 8(a) TSCA – takes effect 120 days after this publication.

The new rule mandates reporting to the EPA by the following companies:

  1. Companies that plan to manufacture or process nanomaterials
  2. Companies that already manufacture or import nanomaterials

Manufacturers, importers, or processors must electronically supply information to the EPA one time about the (planned) volume of production and the manufacturing process. Companies that are newly producing nanomaterials and that wish to market them, must notify the EPA 135 days before the intended start of production.

As defined by the EPA, nanomaterials are solid particles or collections of particles with dimensions at the nanoscale – approximately 1-100 nanometers (nm). As a comparison, consider that human hair has an average width of 80,000–100,000 nanometers. The rule applies only to substances whose nanoforms display different properties than the traditional forms. The rule does not apply to substances that contain only 1% (by weight) of nanomaterials.

Europe does not have a similar reporting rule. The EU Commission has rejected the setup of a nanoregister. Instead, the ECHA operates nano-observatory sites that collate existing information. A good overview of nanomaterials can be found in the response given by the government to a parliamentary inquiry (German only) on the transparency of nanomaterials on the German market.

Are you involved in the manufacture of nanosubstances or do you deal with nanomaterials? Ensure that you have free access to the market for your products and that your products are compliant. Contact us at reach@kft.de.

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EU Inspects Safety Data Sheets

The EU wants to improve the safety of employees who deal with hazardous materials at their companies. That’s why the ECHA began an enforcement project (REACH-EN-FORCE Project 5) at the beginning of this year. As part of the initiative, inspectors in 28 EU countries will check the completeness and correctness of data in safety data sheets and exposure scenarios. The ECHA expects to present a final report in the fourth quarter of 2018.

The inspectors specifically want to determine to what extent the extended safety data sheets contain the information that the manufacturer’s chemical safety report requires. They also want to see if the exposure scenarios are implemented according to the health and safety regulations. The effort has two goals:

 To provide employees with information on the risks involved and to give them the correct safety information

To enable the inspectors to see how well information is pass on along the supply chain

One provision of Article 125 of REACH requires that member states regularly monitor proper implementation of the regulation. In Germany, for example, individual states are responsible for this task. The EU supports these activities across all countries and has established a Forum for Exchange of Information on Enforcement. The Forum consists of a network of various agencies that handle legal implementation of REACH, CLP, and PIC in EU countries, Norway, Liechtenstein, and Iceland. Each country has a representative in the Forum. The representatives suggest projects, like the REACH-EN-FORCE 5 project, and then coordinate and evaluate the projects.

The creation of almost every country-specific version of safety data sheets has been one of our core competencies for many years. If you have any questions, please contact us at sds@kft.de.

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