CLP: Tenth Adaptation to Technical and Scientific Progress Published

The EU Commission has published Regulation (EU) 2017/776, which was issued on May 4, 2017. Experts speak of the new regulation as an ATP, an adaption to technical and scientific progress. Publication marks the tenth time that the CLP Regulation (Regulation (EC) No. 1272/2008 – CLP Regulation) has been modified to consider new technical and scientific developments. The new law went into force on May 25 and applies as of December 1, 2018.

The changes implement Acute Toxicity Estimates (ATE) for substances that help to harmonize classification of mixtures. Moreover, in Annex VI the classifications for 37 substances were revised and included.

All substances (as of December 2010) and all mixtures (as of June 2017) within the EU must be classified, labeled, and packaged according to the requirements of the CLP Regulation. See our blog entry, CLP: 10. Changes on the Way, and our article, CLP: Transition Period for Hazardous Mixtures Expires in June.

If you have any questions about what you need to consider in terms of the CLP Regulation, please contact us at clp-info@kft.de.

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EU Publishes Checklists on Cosmetic Ingredients

The EU Commission has published checklists for companies that want to market cosmetics and that must supply information to the EU before doing so, as part of the notification process. The lists help companies and managers of the safety inspection agencies check to see if all the required data is present and if the form and content of the dossiers are correct.

Cosmetics are subject to special safety inspections because they come into direct contact with the skin. The obligations of manufacturers and importers are defined in the EU Cosmetics Regulation. Notification is one of the obligations that the regulation places on companies. Notification means that before a cosmetic product is brought to market, it must be entered in a central portal of the EU Commission, the Cosmetic Products Notification Portal (CPNP). The obligation is defined in Article 13 of the EU Cosmetics Regulation.

The same requirement applies to cosmetics that contain nanomaterials (Article 16 of the regulation). These notifications are also to be entered in CPNP at least six months before the product is placed on the market. The German Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit: BVL) provides important information (in German only) about the notifications required for cosmetics.

The information provided in the notifications on cosmetics and their recipes is tremendously important for poison information centers. It helps them offer rapid assistance in cases of allergic reactions and other incidents.

The information is just as important to the Scientific Committee on Consumer Safety (SCCS). Its members inspect critical contents (specific dyes, preservatives, nanomaterials, and allergens) and evaluate the risks involved in using the materials.

That’s where the checklists come into play. They are to accelerate the safety inspection process and prevent submission of incomplete documents.

We are pleased to support you regarding all tricky legal issues related to the cosmetics regulation. Please contact us at cosmetic@kft.de.

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Brexit: British Chemicals Industry Opposes Separate British Compliance Regulations

Seven of ten companies surveyed fear that separate British compliance regulations will have negative effects on their trade relations with the European Union. That’s the finding of a survey of the British Alliance of Chemical Associations (ACA), the results of which were provided only to the news platform ChemicalWatch.

The ACA is a group of 11 trade bodies and represents the interests of more than 1,000 predominately small and midsize enterprises in the chemicals and affiliated industries. Two-thirds of the firms are headquartered in Great Britain.

More than 100 firms participated in the survey. Three-quarters of them see Brexit as a risk and also consider REACH and CLP as important to their operational business. More than half of the companies regard a free-trade agreement with the EU as less helpful, and every fifth company would even consider moving their business out of Great Britain.

For most of the small and midsize companies, high levels of investment in regulatory services are a significant burden. They indicate that they invest about 15% of their profit in compliance measures. Some 62% of respondents believe that separate British regulations would increase that figure.

A survey of managers conducted by the British Coatings Federation (BCF) found similar statements. The BCF has summarized the results of the survey in a closing report. In this survey as well, three-fourths of companies spoke against separate British regulations. And the attitudes toward REACH are even clearer. Nine of ten companies regard REACH as having the highest relevance possible. And 82% of the companies regard CLP the same way.

If you need support with issues related to REACH or Brexit, please contact us at reach@kft.de.

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China Seeks to Ban Hazardous Substances from Consumer Products

At the end of March, the National Consumer Product Safety Standardisation Technical Commission in China announced (in Chinese only), that it wants to ban certain chemical substances from consumer products in the future. The substances involved include:

  • Heavy metals such as cadmium, chromium (VI), lead, mercury and nickel
  • Organic chemicals such as benzene, BPA, dyes, polycyclic aromatic hydrocarbons (PAHs), phthalates, polybrominated biphenyls (PBBs), polybrominated diphenyl ethers (PBDEs) and short chain chlorinated paraffins (SCCPs)
  • Organometallic compounds such as organotins and salts

According to the international inspection company SGS, the Chinese plans align with various national and international standards, including:

The list also includes three substances that REACH does not limit: benzothiazole-2-thiol (MBT), antioxidants (2, 2) 6-di-tert-butyl-p-cresol, and 2,2′-methylene-bis (4-methyl-6-tert-butylphenol).

We know the market and the regulations on chemical compliance in Asia. Please contact us at sds@kft.de.

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Turkish REACH to Arrive in Summer

“We expect publication of the Turkish REACH regulation in summer,” says Melih Babayigit, general director of CRAD, a Turkish chemical compliance service provider, at the KFT Info Day on May 11 in Darmstadt. The new law (abbreviated as KKDIK in Turkish) has already been signed by the minister of the environment and was sent to the office of the Turkish prime minister a few weeks ago. As soon as the prime minister gives the green light, the law will be published in the official journal and take effect six months later. KKDIK will then apply in full and replace three previous laws that had previously been in effect:

  • Chemical Inventory and Control Regulation (CICR 27092)
  • Regulation on Restrictions for the Manufacture, Marketing and Use of Certain Dangerous Substances & Preparations (27092)
  • SDS Regulation (29204)

 

The new law consists of 12 titles, 66 articles, and 17 annexes – for a total of 405 pages. “I get a lot of questions about an English translation of the correct version, but that would not make a lot of sense. About 95% of the new law is identical to REACH. In other words, the entire regulation was translated almost one-to-one into Turkish, says Babayigit. But KKDID does not include Articles X–XIII of REACH because those articles relate to the ECHA and the classification and labeling of substances. Those considerations are irrelevant for Turkey, where the ECHA plays no role and the 28848 SEA Regulation has played an analogous role since December 11, 2013.

It should be noted that all safety data sheets must be created by a certified employee in Turkish. Chemical names must also be given in Turkish, especially for substances listed in Annex VI of the SEA Regulation.

Data entry and transmission in Turkey occurs over the KKS system, which is similar to the system used for REACH. However, KKS features less functionality – it is missing a bulk registration utility, for example.

Any companies affected by the law must consider the deadlines it defines. If it appears, as expected, in summer, manufacturers or importers who want to market a substance in a quantity greater than one ton before December 31, 2020 must have it preregistered between January 2018 and December 31, 2020. After December 31, 2023, substances must be registered before they can be marketed. You can also find information on the deadlines in an article by Melih Babyigit in the current issue of Turkchem Magazine.

You can also download the following presentations given by Melih Babayigit:

Chemical Control Regulation in Turkey – Notification & Registration Schemes

Product Registration & Notification Regulations – Biocidal Products and Detergents

We have worked very successfully with our Turkish partner CRAD for several years. If you operate in the Turkish market, please contact us at sds@kft.de.

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Consumer Protection: New Apps for Data on Hazardous Materials in Everyday Products

The German Federal Environmental Agency (Umweltbundesamt: UBA) and the German Federation for the Environment and Nature Conservation (Bund für Umwelt und Naturschutz Deutschland e.V.: BUND) are offering consumers new apps. The software can be used to contact manufacturers for information on the presence of substances of very high concern (SVHC) in everyday products.

With the app from the UBA, Scan4Chem, users can scan the bar code of a product and automatically transmit a query to the supplier, who must fulfill the request within 45 days. A direct query about the contents, however, is enabled only if the information is stored in the related database.

That is already the case with the BUND app, ToxFox, although it is primarily geared to cosmetic products. According to BUND, ingredient information on more than 80,000 personal care products is available. The app is also optimized for children’s toys, and other product groups are to follow soon. But consumers can submit queries even if the system does not yet contain information about questionable contents. In such cases, BUND redirects the query to the manufacturer. And BUND also supplies handy user guide (in German only) for the app.

According to Article 33 Section 2 of REACH, manufacturers and importers are obligated to provide information as soon as the concentration of a critical substances in a product crosses the threshold of 0.1% by mass. The products and objects covered include household goods, textile, shoes, sporting equipment, furniture, home-improvement products, electric and electronic devices, vehicles, and packaging.

SVHC include substances that:

  • Are carcinogenic, mutagenic, and toxic to reproduction
  • Are poisonous and persistent and that concentrate in organisms
  • Have hormonal affects

These substances are new registered at ECHA 173 SVHC.

We are familiar with the laws surrounding the use of SVHC. Please contact us at reach@kft.de.

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Vietnam Updates Chemicals Inventory List

Vietnam’ s Ministry of Industry and Trade (MOIT) has published an updated version of the National Chemicals Inventory and a parallel Announcement (in Vietnamese only). The list now contains entries for 4,927 substances. That number includes about 1,500 more substances than the first version, which was published at the end of last year.

Companies can comment on the list and suggest additions by contacting the ministry. ChemicalWatch has indicated that substances not on the list will be considered new and require registration.

Vietnam’s chemicals law dates from 2007. Its provisions cover how to work with chemicals and the obligations that companies have when dealing with chemicals.

If you operate on the Vietnamese market, we would be pleased to support you. Contact us at reach@kft.de.

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