Experts Discuss Platform for Chemical Data

Discussions about the development of a platform for trade and the exchange of chemical data is off to a flying start. As part of a landmark conference, EU Chemicals Policy 2030 – Building on the Past, Moving to the Future, held in Brussels at the end of June, representatives of the EU, the ECHA, industry, and industry associations exchanged ideas about the possibility of creating a kind of “Netflix of data.” The creation would be a fee-based platform that gives users access to studies and data on chemicals. The EU Commission and the Danish Environmental Ministry organized the conference.

The experts opined that only such a platform can ensure uniform risk assessment and reputable risk management. The platform would enable companies to access data and significantly simplify the registration of chemicals in countries with legislation similar to REACH – South Korea and Turkey, for example.

Sylvie Lemoine, product stewardship director at CEFIC, is excited about the project. However, she told the conference that it is too early to say anything about concrete plans. ECHA director Björn Hansen was also open to and positive about the idea of such a platform. The problem, he said, is less about the data, which is available, and more about how knowledge is coordinated and made available to the responsible stakeholders. For example, Hansen suggested summarizing scientific publications in journals in the IUCLID format.

At the same time, he appealed for joining information from animal experiments and in-vitro tests. In practice, that can mean that every time a chemical is tested, a sample can be sent to the EU’s Joint Research Centre (JRC). Scientists at the center could then produce toxicological data and compare it with data from animal experiments.

The EU has provided the background reports of the conference.

We have supported companies with registrations in the context of SIEF for many years. If you have any questions, please contact us at reach@kft.de.

Posted in Allgemein, REACH | Tagged , , , , , | Leave a comment

For the First Time, the ECHA Classifies Chemical as an SVHC Based on Its Environmental Mobility

In the future, the ECHA Member State Committee (MSC) could classify persistent chemicals that spread rapidly in the environment as substances of very high concern (SVHC). At their meeting at the end of June in Helsinki, committee representatives created a precedent by classifying 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid (HFPO-DA) and its salts and acylhalides as SVHCs for the first time, based on their environmental mobility. The ECHA will include newly identified SVHCs in the candidate list in July 2019.

HFPO-DA (nicknamed the forever chemical) and its derivatives are also called GenX chemicals. They serve as a substitute for PFOA in the manufacture of fluoropolymers.

In a conversation with Chemical Watch, the chair of the ECHA committee, Charmaine Ajao, spoke of a very important milestone. Environmentally mobile chemicals represent an equivalent level of concern (ELOC) as carcinogenic, mutagenic and reprotoxic (CMR), persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) substances. Dutch and German environmental agencies have targeted mobile hazardous chemicals for some time.

The Dutch Ministry for Infrastructure and Water Management submitted the proposal to classify HFPO-DA as an SVHC and described the properties of the substances and their effects on the aquatic environment. They are highly soluble in water, which means that they have a small chance of being adsorbed. When they sink and move through ground layers, they do not adhere at all to sediment or do so only poorly. Exactly this property makes them so mobile that current water-purification processes cannot capture them.

The ECHA committee also discussed the effects of the substances on human health. Some studies indicate a carcinogenic effect for HPFO-DA, along with endocrine disruptions. However, most tests to determine bioavailability and bioaccumulation are targeted toward fat-soluble chemicals, not water-soluble chemicals.

Critics have addressed exactly this point. A spokesperson for Chemours, an HFPO-DA manufacturer told Chemical Watch that unlike previous compounds, HFPO-DA has been shown to be eliminated from the body quickly because of its good water-solubility.

The European Chemical Industry Council (CEFIC) also criticized the classification of chemicals based on ELOC. The classification criteria are too vague for CEFIC, as stated in a reflection paper presenting its arguments and concerns.

Protect your products as soon as possible and ensure their legal compliance. We are pleased to assist you at reach@kft.de.

Posted in Allgemein, REACH | Tagged , , , , | Leave a comment

Planned Allergen Ban in Textiles: Call for Public Consultation

In our blog entry France and Sweden Want to Ban Allergens in Textileswe reported on the proposal that the two countries presented to the ECHA. From June 19 to December 19, 2019, you can make your position on the proposal known. You can find more information on the ECHA Web siteThe ECHA has also published guidance on the consultation.

After the consultation, the Risk Assessment Committee (RAC) and the Committee for Socio-Economic Analysis (SEAC) will assess the ban. The RAC position is expected in May 2020, and the SEAC analysis in July 2020. The EU will then decide about making the proposal part of Annex XVII of REACH.

Will a possible ban affect you? We would be pleased to advise you. Simply contact us at reach@kft.de.

Posted in REACH | Tagged , , , , | Leave a comment

Provisions of Chemicals Laws in South Asia – Dr. Tobias Eger to Speak at Lexxion Seminar on International Chemicals Law

Lexxion publishers has invited Dr. Tobias Eger to speak at its Seminar on International Chemicals Law on September 26–27, 2019 in Frankfurt. KFT’s expert on East Asia will discuss the newest developments in chemicals law in Malaysia, Vietnam, and Philippines.

The Asian chemicals market continues to grow. However, the dynamism of growth has suffered because of the trade conflict between the United States and China. But China and Japan continue to count among the drivers of growth, and other countries like Korea and those in South Asia also profit from it. These countries adopt complex chemicals regulations after the pattern of REACH little by little – not least because of the increased number of accidents. Countries that operate in these markets must be familiar with and observe such provisions.

In his presentation, Dr. Eger will report on the regulations being adopted in Malaysia, Vietnam, and the Philippines.

In Malaysia, for example, CLASS Regulations (Classification, Labelling, and Safety Data Sheet of Hazardous Chemicals) have been in effect since 2013. The regulations define the requirements for communicating hazards, which are to be supplemented by the end of the year. In the future, the changes would require that companies need a Letter of Approval from the appropriate agency, the Department of Occupational Safety and Health (DOSH). Imports would be allowed only after the document has been obtained.

Special provisions in Malaysia require that safety data sheets (SDS) and labels be created in English and Malaysian (Bahasa Malaysia) and that SDS be updated regularly. Furthermore, companies located in Malaysia must submit annual reports on their safeguards to government agencies.

Last year, Vietnam created a national chemical list that now contains 31,745 chemicals. The list is published, but not based on any legal text. Companies are now asked to supplement the list. The information required on labels is particular to Vietnam. The label must show both the classification according to the GHS (currently UN GHS 3rd Rev.) and fulfill the requirements of the Law on Good Labeling.

In the Philippines, chemicals must be listed in various registers according to the risk that they pose:

  • Registered chemicals (Philippine Inventory of Chemicals and Chemical Substances: PICCS)
  • Restricted chemicals (Philippine Priority Chemicals List: PCL)
  • Prohibited chemicals (Philippine Chemical Control Order: CCO)

In March, the environmental agency tightened the requirements for PCL chemicals, so that dealers, importers, and manufacturers now require a certification. The measure was taken to enable the Philippines to monitor the flow of goods from importers to end consumers better.

If you have any questions on this topic, please feel free to contact us at sds@kft.de.

Posted in KFT, SDS | Tagged , , , , , | Leave a comment

EU Council of Ministers Approves New Version of the POP Regulation

In mid-June, the EU Council of Ministers approved a new version of the regulation on persistent organic pollutants (POPs) and issued a press releaseThe new version replaces Regulation (EC) No 850/2004The goal of the revision is stricter control of brominated flame retardants like decaBDE, which is frequently used in plastic electronics and auto parts.

The POP Regulation is binding on all member states of the EU. The road to the new version was arduous. The controversial issue was the limit for polybrominated diphenyl ethers (PBDEs), including decaBDE. The European Parliament had first suggested a limit of 10 mg/kg or 0.001% by weight in substances, mixtures, and objects. However, this value is considerably lower than that of the 0.1% allowed by REACH.

Numerous organizations, including associations of the automobile and recycling industry, were up in arms. They charged that the strict limit would make it virtually impossible to recycle automobiles and electronic devices. They expressed their concerns in a joint letter and called for a more generous threshold.

The EU agreed to the request. The current version sets a limit of 1,000 mg/kg for the total of PBDEs in waste. Nevertheless, the EU Commission will evaluate this upper limit and may cut it half, to 500 mg/kg in the next two years. France and Sweden called for the reduction in a joint statement.

If you work with POPs and need support, please contact us at sds@kft.de.

Posted in SDS | Tagged , , , , , | Leave a comment

South Korea Issues New Instructions for Substance Preregistration

Shortly before the expiration of the preregistration period for existing substances at the end of June 2019, the South Korean Ministry of Environment (MoE) has issued additional instructions for two special cases (in Korean only).

The first case involves substances of unknown or variable composition, complex reaction products, or biological materials (UVCB). The second deals with substances for which foreign vendors or manufacturers have not yet supplied any information because of confidential business information (CBI). The nature of the information meant that companies were unable to deliver any information at all to South Korean authorities. More and more companies sought advice from the Korea Environment Corporation (KECO), which handles preregistrations for the MoE.

The Ministry has now reacted and asked companies to submit what information they have before the deadline – even if it’s incomplete. They now have until September 30 to supply the missing information.

For UVCB substances, such as petrochemical mixtures, the following information is required:

  • Name, contents, classification, and labeling of the mixture
  • Proof that the substance was manufactured and/or imported before 1991 (through an import declaration, for example)
  • Documentation of information on the manufacturing or synthesizing process.

Any available analysis data on the mixtures, such as chromatographic data, should also be supplied. If the UVCB substance is also carcinogenic, mutagenic or reprotoxic (CMR), comprehensive information on the classification and labeling is required.

Foreign manufacturers must appoint a sole representative to complete this task.

If information is missing because of CBI concerns, companies should provide the data available to the companies at preregistration. They must also prove that they have requested the required data from foreign manufacturers. Data and correspondence should then be conducted by e-mail, not the usual IT system.

We have worked with our partners in South Korea for years. We can handle the preregistration and registration of chemicals and maintain the marketability of your products. If you import products into South Korea, please contact us at reach@kft.de.

Posted in REACH | Tagged , , , , , , | Leave a comment

Market Surveillance Uncovers Failure of Dental Hygiene Products to Meet Legal Requirements

In particular, tooth whiteners are often deficient. A CMR substance, sodium perborate (German only), was found in one sample, and an excessive amount of hydrogen peroxide was found in another. Those are the findings the Official Cosmetics Control Laboratories (OCCLs) discovered in a market surveillance project in 2013-17. The European Directorate for the Quality of Medicines & HealthCare (EDQM) has issued a press release on the findings.

During the project, a total of 261 samples were taken at 13 laboratories. Almost half of the samples examined were bleaching toothpastes. A little more than 20% were bleaching gels. The rest were tooth whiteners, mouthwashes, and other cosmetics. Three of four products were manufactured in Europe. The most defects were found in tooth whiteners: Paint-on (brush-on) whiteners (78%), tray-based tooth whiteners (59%), whitening strips (53%), and whitening gel (45%).

Many of the products were not registered through the Cosmetic Products Notification Portal (CPNP), the online notification system of the European Commission, and the labels of many products wrongfully carried the CE symbol.

The manufacturers removed some of the defective products from the market on their own initiative. National agencies issued sales prohibitions for the others.

In October of this year, the EU will add 12 substances of very high concern (SVHC), including sodium perborate to Annex XIV of the REACH Authorization List.

Ensure the legal security of your products as soon as possible. Contact us at cosmetic@kft.de.

Posted in Cosmetic | Tagged , , , , | Leave a comment