Hazardous Chemicals in Toys: Member States Urge Quick EU Action

The ministers of eleven member states of the EU (Belgium, Czechia, Denmark, Finland, France, Hungary, Lithuania, Luxemburg, Netherlands, Norway, and Sweden) are urging stricter threshold values for hazardous chemicals in toys. In a joint letter to Elżbieta Bieńkowskathe Commissioner for Internal Market, Industry, Entrepreneurship, and SMEs, the ministers pointed out various delays and appealed to the EU to update Directive 2009/48/EC on toy safety quickly.

As early as December 2018, the EU Expert Group had agreed on lowering the threshold values for aluminum, based on new scientific evidence. But that decision has not yet been implemented in the Directive. The authors of the letter therefore urged the EU Commission to vote on new limits for aluminum, formaldehyde, and aniline at its meeting in June, 2019.

The authors also want to amend the Directive so that in the future, its thresholds also cover toys for children over the age of three. One reason for this measure is a new type of toy. Squishies are a children’s toy made from PU foam that look cute and smell like caramel or cocoa. However, Danish studies have shown that squishies emit hazardous chemicals. Please also read our article on this topic EU Safety Gate Issues Warning About Hazardous Products: Toys Are the Front Runners.

In addition, say the authors, slime and modeling clay often contain preservatives that do not have any threshold limits in the Directive for toys used by children older than three.  

In closing, the ministers criticized the failure to revise the technical documentation and the explanatory guidance document since 2016, even though agreement has been reached on the required changes.

Ensure the safety of your products at all times. We can help. Contact us at reach@kft.de. 

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France and Sweden Want to Ban Allergens in Textiles

The French Agency for Food, Environment and Occupational Health and Safety (Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail: ANSES) and the Swedish Chemical Oversight Agency, KEMI, have proposed that the ECHA ban or at least sharply limit skin sensitizers that can be contained in textiles, leather, furs, and skins. The proposal means that all substances classified as skin sensitizers according to the CLP regulation would be affected.

ANSES indicates that more than 1,000 substances would be involved. As part of a study, the Agency has already identified the chemicals. The Swedish KEMI had co-directed the risk management option analysis (RMOA).

In their Annex XV Restriction Report, the authors propose the following thresholds (among others):

  • 1 mg/kg for chromium VI compounds (textiles, leather, furs, and skins)
  • 130 mg/kg (textiles) and 110 mg/kg (leather, furs, and skins) for nickel and its compounds
  • 70 mg/kg (textiles) and 60 mg/kg (leather, furs, and skins) for cobalt and its compounds
  • 75 mg/kg for formaldehyde (textiles, leather, furs, and skins)
  • 250 mg/kg (textiles) and 210 mg/kg (leather, furs, and skins) for 1,4 paraphenylene diamine
  • 130 mg/kg (textiles) and 110 mg/kg (leather, furs, and skins) for other substances classified as skin sensitizers

As stated in the ANSES press release (French only), alternatives already exist, especially for disperse dyes. The use of diisocyanates can also be avoided without any technical production problems.

The numbers show the value of the proposed restrictions. An estimated four to five million EU citizens are already allergic to chemicals contained in textiles and leather. According to a KEMI press release (Swedish only) some 45,000 to 180,000 additional persons come down with such allergies every year.

The ECHA will introduce a public consultation on the proposal from the two countries in the coming weeks. Afterwards, the Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC) will develop an opinion on the proposal. The EU will then use the opinion to decide on incorporating the proposal into Annex XVII of REACH.

We are pleased to advise you about the legal implications of the new regulation for your products. Please contact us at reach@kft.de.

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Poison Centers: ECHA Opens Submission Portal for Hazardous Mixtures

As of April 24, companies can access a new online-tool provided by the ECHA that supports the preparation and transmission of data on hazardous mixturesCompanies can create information in PCN format, which is compatible with IUCLID and transmit it to the responsible agencies in member states. The agencies then provide the information to poison centers, which can provide rapid medical advice in the event of an emergencyThe tool significantly reduces the administrative efforts required of companies that market their mixtures in multiple countries and must therefore transmit information to several member states.

But there is one catch: The current version offers only basic information, and an enhanced version is to be released only at the end of the year. That does not give companies much time to act, given that Regulation (EU) 2017/542 takes effect on January 1, 2020. Annex VIII is the sticking point of the Regulation. Article 1 of the Annex states that importers and downstream users have an obligation to provide information on mixtures for consumer use as of January 1, 2020. These mixtures are responsible for most emergency calls. The obligation to provide information on mixtures for professional use applies as of January 1, 2021, and it applies for mixtures used industrially as of January 1, 2024.

Because of the short time available, the Chemical Industry Council (German only) and several other associations have called for an extension of the requirement, particularly because of the tremendous effort that companies must expend to provide the information. For example, each recipe requires the creation of a Unique Formula Indicator (UFI) code that must appear on the label and the safety data sheet. Because formulators and importers are dependent on the information provide by their vendors, some uncertainly also exists.

For more information and links related to the topic, see the Web site of the ECHAYou can also read our article, Poison Centers: ECHA Offers New Support Services.  

Companies can reduce their administrative effort by keeping their safety data sheets up to date at all times. We can offer concrete advice on this task

The creation of almost every countryspecific 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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Titanium Dioxide: Not Classified as Probably Carcinogenic for the Time Being

At its meeting in April, the REACH regulations committee crossed out “classification of titanium dioxide” on its agenda at the last minute, thereby postponing a decision on how titanium dioxide products will be classified in the future until the fall.

As early as September 2018, the EU Commission suggested placing powdery titanium dioxide and powdery mixtures that contain 1% or more of titanium dioxide particles (≤10 µm) in Annex VI of the CLP Regulation as probably carcinogenic by inhalation (Category 2, classified with GHS08 and H351).The French agency ANSES got the ball rolling.

Since then, industry representatives, including the German Chemical Industry Council (in deutsch) and the Paint and Printing Ink Association (VDL) criticized the new classification. The manufacturers of paint, lacquers, and printing inks would bear the brunt of the decision, given that they consume about 60% of the titanium dioxide pigments that are produced.

The critics argue that the carcinogenic effects of titanium dioxide are not an intrinsic property of the chemical itself, but a general particle effect that applies for all dusts. Martin Engelmann, executive director of DVL, called for a total EU harmonization of threshold values for dust at the workplace. He stated that consumers rarely come into contact with titanium dioxide powder, so that danger for consumers is not an issue.On its Web site, the VDL provides information that includes a file on titanium dioxide with numbers and facts about the white pigment (both available in German only).

In fact, the proposed classification would have wide-reaching consequences. The labels of lacquers and paints would have to include hazard pictogram GHS08. Use of the chemical in cosmetics like toothpaste and sunscreen might also apply, as would limitations on its use in materials that come into contact with food, dyes, and medications. An enhanced classification would also affect the waste industry, since 1% of titanium dioxide in waste would make the waste hazardous, meaning that it would have to be disposed of in an approved facility. 

Does your company deal with titanium dioxide? Do you need legal security
when dealingwith this substance? If so, please contact us at 
reach@kft.de. 

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Personal Protective Equipment: Transition Period Ends on April 20, 2019

Since April 21, 2018, the new PPE Regulation (EU) 2016/425 is in effect. This Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) which is to be made available on the market. After April 20, 2019, manufacturers may no longer introduce personal protective equipment (PPE) that meets the requirements of the previous regulation, 89/686/EEC, into the market. That was announced by the German Association of Technical Trade (Verband Technischer Handel: VTH) on its Web site (German only).

However, if manufacturers have marketed PPE products before the cutoff date, they may still be sold after April 20. That’s the determination of new PPE Regulation.

Employees are required to wear PPE when they are exposed to hazards at the workplace. What constitutes a hazard (in Germany) is defined by the hazard assessment laid out in §5 of the Working Conditions Act (German only). The employee supplies the required PPE.

Annex I of the PPE Regulation describes the risks the PPE is to protect against.

Category I of the Annex covers PPE for minor risks, including cases where employees could suffer superficial injuries from machinery or come into contact with mildly aggressive cleaning agents. Category III covers only PPE that is to be worn when facing risks with serious consequences, such as irreversible health effects, or even a risk of death. Category II covers PPE for all other risks.

The new PPE Regulation means that products like ear protectors, life vests, or PPEs that protect against cuts from handheld chain saws will belong to Category III in the future. Another new element is that dealers now have greater responsibility. In the future, dealers and importers must ensure that their goods have been inspected and that they have the required certificates.

Safety at work is an important aspect. Carefully maintained safety data sheets contributesignificantly
to this.

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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ECHA Issues Its First Annual Report: “Mapping the chemical universe to address substances of concern – Integrated Regulatory Strategy”

In April 2019, the ECHA published its first annual report Integrated Regulatory Strategy. The report serves the ECHA and the responsible agencies in the member states as a starting point, given that the ECHA wants to develop an overview of all registered chemicals by 2027. It wants to identify the status quo of substances of concern and to determine which chemicals require additional hazard information or risk management measures.

Based on quality and varying potential hazard levels, the ECHA has defined three pools. The differentiation helps set the priorities of planned follow-up measures.

  • Pool 1: Chemicals with a high priority for risk management. 
  • Pool 2: Chemicals that are concerning for the environment or health and that required more data to be generated or whose data must still be evaluated. 
  • Pool 3: Chemicals of low priority whose handling and use is covered by current legislation and for which the authors of the report do not see a need for further action.  

An important interim goal of the ECHA is to assign all 4,700 registered chemicals in quantities greater than 100 tons to one of the three pools.

As the ECHA press release indicates, only 40% of these chemicals have been mapped so far. Most substances land in Pool 2, which currently contains 1,300 substances. A great deal of work awaits the authorities in the next few months, since 2,700 chemicals still need to be classified.

The authors recommend the following for the future: 

  • Additional collaboration and coordination among agencies are needed. 
  • Chemical data for risk management must be made available more quickly and more comprehensively. 
  • The harmonization of classification and labeling should be a priority because they simplify risk management and legislation.  
  • The prioritization and appropriateness of outstanding follow-up measures is to be reviewed. Regulatory risk management is to move ahead, particularly for substances of high concern.
  • The quality of registration data must be improved, especially of chemicals that have a high potential for exposure and those that have incomplete data. 

Do you have questions concerning the registration of substances or do you plan a registration? Please contact us at any time under reach@kft.de. 

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Australia: Early Regulatory Changes to Take Effect Immediately

The Australian government has put new chemical regulations, or “early regulatory changes” into effect. With this action, the nation wishes to simplify the import of chemicals that are not hazardous to health. Such substances include polymers of low concern (PLCs). The following changes apply to importers:

  • PLCs are now exempt from notification. 
  • The criteria list for PLCs has been expanded, so that a greater number of polymers now fulfill the PLC criteria. 
  • Cosmetics imported in small quantiles no longer require safety data sheets (SDSs) or labels.  

Further details are available from the NICNAS, the responsible agency. The site also provides manufacturers and importers with a questionnaire they can use to determine if their polymer is assigned to the group of PLCs. 

NICNAS has also changed the definition of what is to be understood as a “new synthetic polymer.” With the change, Australia wants to align its definition with those of the United States and Canada. According to the change, a new synthetic polymer exists when the polymer consists of: 

  • A combination of monomers and other reactive components each representing greater than 2% by weight, being a combination not previously listed in the Australia Inventory of Chemical Substances (AICS). 
  • A weight greater than 2% of a monomer that is not listed in the inventory as a component of a synthetic polymer. 

If you operate in the Australian market, you can contact us at reach@kft.de. 

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