EU Safety Gate Issues Warning About Hazardous Products: Toys Are the Front Runners

Toys continue to be contaminated with hazardous chemicals. According to a current EU report, Safety Gate: just a click to keep away from dangerous products, toys are one of the top three product categories most frequently reported to the early warning system formerly known as RAPEX, which stands for rapid exchange of information (toys 31%; commercial vehicles 19%; and clothing, textiles, and fashion 10%).

Chemicals and injuries (25% of notifications) are the most common reasons for product notifications. The number of such notifications grew by 3% from the previous year.

As indicated in the fact sheet published by the EU, the EU Rapid Alert System for Dangerous Non-Food Products, the number of warnings climbed from 2,201 in 2017 to 2,257 last year. Most of the RAPEX warnings came from Germany (362), followed by France (249) and Hungary (172).

The authors of the EU report have uncovered a new type of toy as particularly problematic: “Squishy or squeezable toys.” The products involved contain hazardous chemicals like n,n-dimethylformamide, n,n-dimethylaminoethanol, cyclohexanone, and triethylenediamine. All these chemicals can cause damage to the eyes, trigger inflammation of mucus membranes, and harm the liver. In its press release of April 5, the EU Commission wrote that more than half of the hazardous products identified come from China.

RAPEX enables quick discovery of such products, so that they can be speedily removed from the market. RAPEX was set up in 2003 for consumer protection and enables swift EU-wide exchange of information on product recalls. Individual states can react accordingly and introduce follow-up measures. Some 4,050 measures, such as a prohibition of sales, stoppage of current sales, recalls, or import prohibitions by customs authorities were undertaken in 2018.

According to the Commission Implementing Decision (EU) 2019/417 of November 8, 2018 the RAPEX Web site was renamed Safety Gate, to inform consumers better. For example, a translation tool is available to make information available in the 25 languages (official EU languages plus Norwegian and Icelandic) used in the countries participating in the system.

A public Web site was developed for Safety Gate, which means that the warnings of all participating national agencies are regularly updated in the system. About 50 warnings are created and published every week on the Internet.

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ECHA Action Plan: Screen All REACH Data by 2027

The ECHA and the EU Commission plan to screen all data on chemicals in quantities greater than one ton by 2027. That announcement was made by ECHA executive director Björn Hansen at an event sponsored by Chemical Watch held in Brussels at the end of March. That approach is also the core statement of the ECHA action plan to be published in June of this year.

The ECHA database currently (April 8, 2019contains information on 22,096 chemicals and information from 93,932 dossiers.

However, gaps exist in many of the REACH registration dossiers. That’s why a closer examination is absolutely necessary, said Sharon McGuinness, chair of the ECHA management board, in response to a query from Chemical Watch. Accordingly, the ECHA has asked national enforcement agencies of EU member states to inspect the dossiers of all registrants in the future, rather than limiting itself to the dossiers of leading registrants.

The European Chemical Industry Council (CEFIC) is also developing an action plan to identify the causes of data gaps. In its initial analysis, CEFIC identified one source of errors: Many registrants provide insufficient justification for the use of alternatives to animal testing.

CEFIC wants to align its action plan closely to that of the ECHA and then publish it on its website.

You can maintain the marketability of your products by updating your dossiers regularly. If you have any questions, we are pleased to offer you support at 

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South Korea: Tracking System for Chemicals on the Way

The State Council of South Korea has approved the implementation of a tracking system for chemicals along with the related modification of the Chemical Control Act (CCA). The draft (in Korean) was presented at the start of April and will now be presented to Parliament. The South Korean Ministry of Environment (MoE) has issued a press release (in Korean) on the matter.

The MoE suggested establishment of such a tracking system as early as May of last year. Politicians hope that the system would create transparency to identify chemicals more quickly and to be able to react in a moretargeted manner in the event of accidents. It is particularly difficult to obtain hazard information for the approximately 8,000 chemicals that are marketed in quantities under one ton and are therefore not subject to K-REACH. 

The ramp-up to the implementation includes assignment of a tracking number (a 15–20-digit code) to all hazardous chemicals manufactured in or imported into the country. The code provides information on the reporting year, the serial number, the country of manufacture, the toxicity of the substance, and whether the substance is part of a mixture or an individual chemical. Companies that manufacture or import these chemicals must place the code on the packaging and the product itself. With this approach, the journey of the substance along the supply and application chains can be traced and monitored at all times.

In the current National Trade Estimate Report (S.318-319), USTR, the United States criticized the planned tracking system. The report states that confidential business information (CBI) is not protected when the components of chemical mixtures must be revealed. It also states that if U.S. exporters cannot meet the requirements of South Korea, exports to the country would probably be reduced. Nevertheless, the United States, says the report, would work together with South Korean authorities to implement the requirements of the law.In the meantime, the South Korean MoE has reacted to the concerns of the USTR (in Korean) and clarified that the law protects CBI at all times: 

  • When tracking a chemical, only the tracking code is visible, not the information that the code represents 
  • The information is given only to the government and not, as previously, to the Korea Chemicals Management Association (KCMA) 

At the same time, the Ministry confirmed that it would examine submissions in terms of data protection and would exchange information in close cooperation with industry when implementing any measures.

Please note that as part of K-REACH, materials can be preregistered until June 30.  

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EU Updates CLP Regulation

The EU Commission has revised Annexes I–VI of the CLP Regulation in light of the latest classification and labeling criteria found in the Globally Harmonized System (GHS). The revision aligns CLP with the sixth and seventh versions of GHS.

Commission Regulation (EU) 2019/521 of March 27, 2019 establishes a new hazard class (desensitized explosive chemicals and mixtures along with explosive articles) and a new hazard category (pyrophoric gases) within the hazard class of flammable gases. The criteria for chemicals and mixtures that develop flammable gas when they come into contact with water were also updated. Some hazard and safety statements were changed as well. These changes required the updates of the related technical rules and criteria in Annexes I–VI of Regulation (EC) No. 1272/2008.

The Regulation takes effect on October 17, 2020.

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EU-Sponsored Project: Risks of EDC Mixtures Underestimated

Mixtures of endocrine-disrupting chemicals (EDC) conceal health risks that are significantly higher for children than the risks posed by individual chemicals. That’s the result of an EU-sponsored project, EDC-MixRiskwhose findings were presented in a workshop, The Chemical Cocktail Challenge, at the end of March in Brussels.

As part of the project, an international team of researchers led by Ake Bergman of the Karolinska Institute in Stockholm spent four years studying how mixtures of endocrine disrupters affect human health. The goal of the project was to improve risk management.

The researchers used data from a Swedish study of pregnant women, the Swedish Environmental Longitudinal, Mother and Child, Asthma, and Allergy (SELMA) study. Based on the data, they created EDC reference mixtures that they then used in experiments with cells and animals. The resulting toxicological data is the key to systematic risk assessments of EDC mixturespress release summarizes the most important findings and data. 

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ECHA Publishes CoRAP List For 2019–21

The ECHA has updated the Community Rolling Action Plan (CoRAP) list. Based on the list, 19 member states of the EU plan to evaluate 100 chemicals in the next three years. The list contains chemicals to be evaluated as part of REACH, which states why a particular chemical is to be evaluated, when the evaluation is to take place, and which country is responsible for the evaluation.

The update plan contains 24 chemicals in addition to those on the previous list, CoRAP 2018–20. The newest additions include three polyfluorinated ethers, HFE-7000, HFE-7100, and HFE-7800 (significant global-warming potential) along with resorcinol (a potential endocrine disruptor).

The 11 member states are to evaluate 31 of the 100 chemicals this year, 44 next year, and the remaining 25 in 2021.

The list is updated annually, so that some entries may be removed when studies indicate that the original suspicions of a hazard are unfounded. Other reasons for removal include the presence of the chemical in a risk management process and a registrant’s decision to stop manufacturing the chemical. However, in the most common cases the evaluation causes the member states to reclassify the chemical, identify it as a SVHC, and limit its use accordingly.

That’s why it’s important for users to stay on top of current developments. The list provides the first indication that a substance will appear in Annex XIV (list of all chemicals requiring authorization) or Annex XVII (list of forbidden substances or those limited to specific uses) of REACH.

Should one of your registered substances be included on the CoRAP list and you may need any support, please contact

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Taiwan and China Control Chemicals Listed in the Stockholm Convention

The Taiwanese Environmental Protection Agency (EPA) (only in Chinese) has entered three persistent organic pollutants (POPs) listed in the Stockholm Convention to its own list of toxic chemicals. The chemicals involved include the group of short-chain chlorinated paraffins (SCCPs), decabromodiphenyl ether (DecaBDE), and hexachlorobutadiene (HCBD).

SCCPs function as flame retardants, plasticizers, and additives in other products. The EPA will now classify them as toxic substances of Class 1. The flame retardant DecaBDE will also be listed in Class 1, along with HCBD, which is used as a solvent in the manufacture of rubber mixtures and as a hydraulic, heat-transfer, or transformer fluid. All these uses will be forbidden in the future. Use of HCBD will be permitted only for research and training.

The Chinese Ministry for Ecology and Environment (MEE) (only in Chinese) is implementing the requirements of the Stockholm Convention and forbidding (since end of March 2019) the production, sale, use, import, and export of perfluorooctanoic acid (PFOA) and it salts, perfluorooctane sulfonyl fluoride (POSF), lindane, and endosulfan. The last two chemicals are used as insecticides and medications against lice and scabies. Because of their persistence and ecological toxicity, PFOA and POSF will be classified as chemicals of concern in the future.

Only PFOA and its salts along with POSF may be used in the future, according to the exceptions given in the Fact Sheet of the Stockholm Convention.

China signed the Stockholm Convention of the United Nations in May 2001 and ratified it in August 2004.

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