China Publishes RoHS 2 Product Catalog and List of Exemptions

The Chinese Ministry for Industry and Information Technology (MIIT) has published a RoHS product catalog (only in Chinese) of electric and electronic products that must meet the requirements of the RoHS regulation and a list of approved exemptions (only in Chinese). Both go into effect on March 12, 2019.

The final version is essentially the same as the draft of the previous year: The same products are listed. However, the updated list specifies the products in greater detail. For example, instead of simply listing television devices, the document distinguishes between traditional cathode-ray tube, rear-projection, OLED or LCD, and other flat-screen televisions with various display techniques.

In general, all the products must comply with RoHS requirements if their use is not clearly defined and they are sold separately. However, some devices, such as certain printers, are exempted from the regulation. Exemptions also apply to products that are listed themselves, but that are part of a larger product that is not listed.

SJ/T 11363-2006 (China RoHS 1) has been the law since March 1, 2007. Its goal is similar to that of the EU RoHS regulation – keeping specific hazardous chemicals out of electronic products.

The MIIT published China RoHS 2 (only in Chinese) on January 21, 2016. Its requirements are very closely aligned with those of the European RoHS 2 of 2011. You can find a detailed comparison and a good overview of RoHS regulations in individual countries at ChemSafetyPRO. Additional information can be found at Questions and Answers on China RoHS 2.

We’d also like to invite you to our Chemical Compliance Day on April 12. A representative of a Chinese agency will join us and provide information on legal requirements in China.

If you have any advance questions, please contact us at sds@kft.de.

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KFT Receives DIN EN ISO 9001:2015 Certification

As of March, KFT Chemieservice has been certified according to the DIN EN ISO 9001:2015 quality management standard by the independent certification body “TÜV Hessen”. “Quality is an outstanding characteristic of our corporate culture. That’s why it was important to us to have an external service provider check all our internal operating processes,” said KFT’s managing director, Karl-Franz Torges.

The goal of KFT has always been to ensure clear responsibilities along with transparent and rapid procedures – to increase customer satisfaction sustainably. “Only when our customers are satisfied are we satisfied and we aspire to improve our processes continuously. Standing still ultimately means going backwards,” emphasized Torges.

That’s why a system should not exist rigidly for several years but lead to a continuous process of improvement. That is exactly the central requirement of the DIN EN ISO 9001:2015 inspector for a certified quality management system.

The DIN EN ISO 9001:2015 quality management standard is the most widely used and most significant German and international standard in quality management (QM). Process orientation and a continuous improvement process are essential guiding principles. All important operating processes are subject to examination according to a simple motto: There is nothing that cannot be improved.

Do you have any questions about certification? Please contact us at mail@kft.de.

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UEAPME Calls for Clarification of Planned Modifications of REACH Fees

The European Association of Craft, Small and Medium-Sized Enterprises (UEAPME), which represents the interests of small and midsize enterprises (SMEs) throughout Europe, has called upon the EU to formulate more clearly its planned changes to the current fee structure. UEAPME expressed its position on this matter in a letter to the EU.

The cause of the criticism is a section that could be disadvantageous to SMEs. The text states: “Where the applicants that are party to a joint application for an authorisation are of different sizes, the highest fee applicable to any of those applicants shall be levied for that application.” In its letter, UEAPME warms that this formulation leaves the exact division of fees open. The situation would create room for conflict between individual negotiators and make the already difficult talks even more challenging.

Representatives of the UEAPME used a sample calculation to illustrate an alternate method for distributing the fees fairly – according to the size of the enterprise. Say that the fee for a large enterprise is €48,690 and one-tenth of that (€4,869) for the smallest company. This would result in the following sample calculation:

  • The total costs of authorization in the UEAPME example are €53,559.
  • The costs (€48,690) are divided by the total cost (€53,559), giving a factor of 0.90909091.
  • The distribution factor would serve as a multiplication factor for additional fees. The large company would pay €48,690 x 0.90909091 = €44,263.64; the small company would pay €4.869 x 0.90909091 = €4,426.36.

The UEAPME states that such a calculation is fair because:

  • All the companies involved profit from the cost distribution equally.
  • The distribution rule protects SMEs from discrimination.

If you have any questions about fees, please contact us at reach@kft.de.

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Eurasian Economic Union Aligns It Regulations with the EU’s RoHS II Rules

In the future, the Eurasian Economic Union (EEU), consisting of a common market and customs union of Armenia, Kazakhstan, Kirgizstan, Russia, and Belarus, wants to keep hazardous substances out of electric and electronic devices. As part of that goal, the EEU has aligned its applicable regulations with the European Union’s RoHS II Directive. The new regulation has been in force since March of this year. The EEU has issued a press release (only in Russian) on the modifications made to the law.

With the new law, the EEU limits to 0.1% by weight the use of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBBs), and polybrominated diphenyl ethers (PBDEs) in electric and electronic devices as well as their components.

The regulation applies to household items, IT and telecommunications services, lighting systems, electric tools, sport and leisure equipment, and vending machines. The regulations do not apply to electric toys, solar modules, photovoltaic installations, many land-based and orbiting products, medical devices, and electric batteries.

EU Directive 2011/65 (RoHS II) has been in force in the EU since January 2013. The Directive was transformed into applicable German law in May 2013 as the Ordinance on Hazardous Substances in Electrical and Electronic Equipment (Elektro- und Elektronikgeräte-Stoff-Verordnung: ElektroStoffV – only in German). Both regulations (ElektroStoffV and EU Directive 2011/65) must be read together because ElektroStoffV does not implement all parts of EU Directive 2011/65.

If you have any questions about the RoHS II Directive, please contact us at reach@kft.de.

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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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