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 Allows Inspections of the Classification and Labeling of Mixtures

At the beginning of the year, the ECHA began another enforcement project (REACH-EN-FORCE-6, REF-6). With this project, the agency wants to see if the classification and labeling of mixtures corresponds to the data in the related safety data sheets. A total of 31 European states are participating in the project, and the ECHA has issued a press release about it.

The CLP Regulation has been binding for mixtures since June 1, 2017. In Germany, the factory inspectorates of individual states are responsible for compliance with the regulation. The EU supports compliance with the CLP rules and has created the Forum for Exchange of Information on Enforcement (Forum) on CLP, REACH, and PIC within the EU for that purpose. Each country has a representative in the Forum. The members propose, coordinate, and evaluate projects like REF-6. Katja vom Hofe is the current chair of the Forum. Last year for the first time, the Forum included a Biocidal Products Regulation Subgroup (BPRS) under the direction of Eugen Anwander.

In addition to routine checks, those responsible for REF-6 may include additional criteria in their inspections, such as whether special requirements for labelling and packaging requirements, for liquid laundry detergent capsules, and for the authorization and labelling of biocidal products are being met.

A closing report covering the results of the inspections is planned for the end of 2019.

We can create safety data sheets in almost all country versions. If you have any questions, please contact us at sds@kft.de.

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Over Two-Thirds of REACH Dossiers Not Compliant

About 70% of the REACH dossiers that have been examined show gaps in the data, some of them
significant. The warning comes from the authors of the Progress Report 2017: Evaluation Under REACH. The evaluation includes summarized data from the past ten years.

According to the report, 69% of the 1,350 dossiers examined for quantities over 1,000 tons and 77% of those for quantities between 100 and 1,000 tons have data gaps.

By the end of last year, the ECHA requested missing information 2,586 times. The missing data covered:

  • Targeted human health hazards: 955 (37%)
  • Ecotoxicity and fate: 662 (26%)
  • Substance identification: 420 (16%)
  • Chemical safety reporting quality: 367 (14%)
  • Physico-chemical properties: 178 (7%)

For Björn Hansen, the director of the ECHA, these figures mean that the group must continue along the chosen path to evaluate dossiers. It must uncover gaps in data and request missing data when waivers cannot be accepted. Hansen continues to count on the good collaboration from all EU states. He is concerned that most of the dossiers have not been updated at all since they were initially submitted.

In the report, the authors provide registrants with a variety of recommendations (Chapter 5). Take a look at the Information on the ECHA-Website and the ECHA press release on the publication of the report.

We are always ready to help you keep all required compliance documents up to date. Please contact us at reach@kft.de.

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ASEAN Cosmetics Committee Bans Four Fragrances

The ASEAN Cosmetics Committee (ACC) of the Association of Southeast Asian Nations (ASEAN) has prohibited the use of four fragrances in cosmetics. The prohibition applies to new cosmetics products as of August 23, 2019 and to those already on the market as of August 23, 2021.

The ban applies to four allergenic fragrances in compounds:

  • Atranol, CAS number 526-37-4
  • Chloratranol, CAS number 57074-21-2
  • 3-and 4-(4-hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde (HICC), CAS numbers 51414-25-6 and 31906-04-4.

HICC is a synthetic fragrance the smells like lilies of the valley. Chloratranol and Atranol are the primary fragrances of natural oak and tree moss extracts.

The EU had prohibited the compounds last year and amended the cosmetics regulation accordingly (see our blog entry).

At its meeting last November in the Philippines, the Association lowered the maximum allowed concentration of methylisothiazolinone (MIT) from 0.01% to 0.0015% – effective on June 1, 2019. In addition, zinc oxide may no longer be used after December 1, 2018 if inhaling it strains the lungs. Yet another directive requires that the label of oxidative and non-oxidative hair dyes state that the user must wear appropriate gloves.

ASEAN is an international organization of ten southeast Asian countries. It is headquartered in
Jakarta (Indonesia). A summit of the ASEAN countries is held every year.

The ACC was created according to Article 10, Institutional Arrangements, of the ASEAN Cosmetic Directive (ACD). Members of the ACC should oversee implementation of the regulation in their individual countries.

The government of Singapore provides a good overview of the ASEAN Cosmetic Directive on the Web site of the Health Sciences Authority (HSA).

For any questions about the legal security of your cosmetics products, please contact us at cosmetic@kft.de.

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What the New German Government Plans for REACH

A new, 179-page coalition agreement (German only) among the CDU, CSU, and SPD
political parties was published on February 7 and approved on February 26. The document contains one passage related to REACH (p. 142).

According to the agreement, the parties want to strengthen REACH in the future. They want the existing chemicals legislation, REACH, to cover products manufactured outside the EU that contain substances of very high concern that can be released into the environment. The document states that the best way to accomplish this goal is to use the restrictions procedure in REACH. The agreement indicates that the regulation of these chemicals is to be accelerated and simplified. The parties also expressly argue that future modifications of REACH should close regulatory loopholes that put European companies at a disadvantage.

In a position paper on the current status of REACH implementation (German only) of
February 2017, the Federation of German Industries (Bundesverband der Deutschen
Industrie) warns of competitive disadvantages for companies headquartered in the EU that can arise during the authorization process. The authorization requirement still does not apply to products imported into the EU that contain chemicals that require authorization. These kinds of products can still be imported into the EU. The authors of the paper argue that this situation can lead to significant disadvantages for EU manufacturers.

If you have any questions on REACH, please contact us at reach@kft.de.

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South Korea Revises K-REACH Rules

The environment committee of the South Korean National Assembly has approved a draft law submitted by the environmental ministry to amend K-REACH. The committee made two crucial changes to the draft.

First, the fines for non-registration of chemicals have been increased dramatically. Instead of 2% of gross sales (as originally suggested by the environmental ministry), companies must now pay 5% of their gross sales as a fine. In especially serious cases, up to five years of imprisonment is threatened. Second, all substances that pose a danger to the environment and health must be registered if they are imported into South Korea in a total quantity greater than one ton. The emphasis on the total quantity was important to the committee to prevent misuse by splitting imports quantities across shipments.

The regulation is to go into effect on July 1, 2018.

The South Korean parliament approved K-REACH on April 30, 2013, and the law took effect on January 1, 2015. Since then, the Toxic Chemical Control Act (TCCA) that had been in effect since 1991 was divided into two parts:

  • K-REACH covered the registration and evaluation of chemicals
  • The Chemicals Control Act (CCA) covered monitoring and handling of dangerous goods. The law also describes how to avoid chemical accidents and how to report serious incidents.

Since the implementation of K-REACH in 2013, the rules in the comparatively new regulation are updated and supplemented on an ongoing basis.

Along with our partner, KTR Europe GmbH, we support companies that operate in the South Korean market. You can reach us with any questions at reach@kft.de.

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EU Gets Serious About Flame Retardants

The EU Commission has forbidden the export of four brominated flame retardants and three additional
substances. The chemicals have been added to Part 1, Annex V of the Prior Informed Consent (PIC) Regulation. The regulation takes effect on April 1, 2018.

As of that date, chemicals and products containing tetra-, penta-, hexa-, and heptabromodiphenyl ethers in concentrations of 0.1% or greater by weight may not be exported if they have been manufactured partially or fully from used or recycled materials. With this prohibition, the EU meets its obligations under the Stockholm Convention, which limits persistent organic pollutants (POPs) now and aims at forbidding them completely in the long term.

Flame retardants that contain halogen are found in a large variety of products, even though the CLP Regulation classifies them a carcinogenic or toxic when swallowed. In a Danish study, scientists found chlorine phosphorus-based flame retardants and per- and polyfluoroalkyl substances (PFASs) in the straps of bicycle helmets. And British scientists found brominated flame retardants in used plastic toys. Scientists at Plymouth University in Great Britain have published a study even more recently.

In addition to the four brominated substances, the prohibition also applies to the solvent hexachlorobutadiene (a possible carcinogen), polychlorinated naphthalenes, and hexabromocyclododecane (HBCDD).

For additional news (in German) about the PIC Regulation, see the publication of Germany Trade & Invest (GTAI).

The PIC Regulation covers the export and import of chemicals that are forbidden or subject to restricted use in the EU. As of February 16, 22 substances are listed in Part 1, Annex V, 186 substances in Part 1, Annex 1, and 87 in Part 2, Annex 1.

Safe products ensure long-lasting relationships with customers. We are here to support you at reach@kft.de.

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Sweden and Scotland Ban Microbeads

Sweden has forbidden the sale of toothpastes, hair shampoos, hair conditioners, body peelings, and shower gels (rinse-off cosmetics), that contain microbeads. The prohibition takes effect on July 1, 2018. Dealers who obtain such products before that date may continue to sell them until January 1, 2019. Products with natural additives like coconut shells or rice kernels are excepted from the regulation.

Extending the ban on microbeads is planned. The EU Commission has engaged the ECHA to prepare an appropriate Annex XV dossier for that purpose.

The Scottish government has also banned the manufacture and sale of rinse-off products as of June 2018 based on a current draft law. We reported on a microbead prohibition in Great Britain in January.

If you have any questions about microbeads or the safety of your products, please contact us at cosmetic@kft.de.

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