RoHS Directive: What’s New?

In the European Union, the amended RoHS Directive (Directive 2011/65/EU of June 8, 2011 on limiting the use of specific hazardous chemicals in electric and electronic devices has been in effect since July 22, 2019. The Directive lists various chemicals that may not be used in electric and electronic devices. Since the effective date, two important revisions have been made for users.

First, as of July 22, 2019, four additional prohibitions on the hazardous chemicals in electric devices have been added to the earlier prohibitions. As published in the amending directive (Directive (EU) 2015/863 of March 31, 2015, the following four phthalates will be forbidden, along with lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), and polybrominated diphenyl ethers (PBDE):

  • Bis(2-ethylhexyl) phthalate (DEHP)
  • Butyl benzyl phthalate (BBP)
  • Dibutyl phthalate (DBP)
  • Diisobutyl phthalate (DIBP)

Second, as of July 22, 2019, Article 2, Section 2 of the RoHS Directive also applies to the devices listed in Annex I under Category 11 that have so far been exempt. These devices include other electric and electronic devices that cannot be assigned to any of the categories already noted.

Annex III of the RoHS Directive lists uses exempt from restrictions. The exemptions have now been expanded because in August, the EU issued a five-year RoHS exemption for the use of DEHP in the rubber components of engine systems. It also approved a five-year exemption for the use of lead in solder of sensors, actuators, and engine control units of combustion engines.

In Germany, the revisions have been realized in the national electronic chemicals ordinance (German only).

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REACH Candidate Lists Expanded to Include Four More Chemicals

The ECHA recently included four new substances of very high concern (SVHC) in the REACH Candidate list. See the related press releaseThe list now contains a total of 201 chemicals.

The new entries include:  

  • Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP) – endocrine disruptor for the environment 
  • 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halides (covering any of their individual isomers and combinations thereof) – equivalent level of concern having probable serious effects to human health and the environment
  • 4-tert-butylphenol – endocrine disruptor for the environment
  • 2-methoxyethyl acetate – reprotoxicant 

Manufacturers and importers who deal with these SVHCs are not automatically required to register them. However, suppliers must inform their customers about the presence of the chemicals by providing safety data sheets. The information must also be provided for mixtures that contain a chemical in the candidate list in a concentration of at least 0.1% by weight – even when the mixture itself is not considered hazardous according to Regulation (EC) No 1272/2008.

When products contain SVHCs in a concentration greater than 0.1% by mass, vendors must notify theECHA, as required by REACH: Article 7, Section 2Vendors also have obligations as defined in Article 33 of REACH: They must inform customers and, upon request, consumers of the presence of SVHCs. 

The Candidate List is updated regularly. Six new SVHCs were added in January 2019.

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Popular Fragrance Forbidden in the EU After August

As of August 23, 2019, cosmetics containing Lyral may not be marketed. That’s the content of EU Regulation 2017/1410 of the Commission, dated August 2, 2017. Article 2 of the Regulation also forbids any sales of cosmetics that contain the fragrance in the UE market after August 23, 2021.

In its opinion paper of June 26–27, 2019, the Scientific Committee on Consumer Safety (SCCS) concluded that fragrances 3 and 4-(4-Hydroxy-4-methylpentyl)-3-cyclohexene-1-carbaldehyde (HICCLyraland 3-Chloro-2,6-dihydroxy-4-methyl-benzaldehyde (Chloroatranolpose a risk to human health and should therefore be prohibited. Lyral occurs naturally in Lilies of the Valley, but both fragrances are responsible for most contact allergies.

At the beginning of this year, scientists at the French the Agency for Food, Environmental and Occupational Health & Safety (ANSES) indicated the presence of critical concentrations of Lyral in disposable diapers.

The ASEAN Cosmetics Committee (ACC) of the Association of Southeast Asian Nations (ASEAN) has also prohibited the use of Lyral fragrances in cosmetics.

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Turkey: Almost 48,000 Preregistrations – Development of the New IT Tool Underway

According to the Turkish Ministry of Environment and Urbanization (MoEU), about 48,000 preregistrations have been submitted so far. Nevertheless, companies have raised concerns about recurring problems with the software of the Turkish ministry (KKS) over the past few months. The software is not compatible with the IT tool used for REACH. 

The ministry wants to drive quick updates of the software to align it with the IUCLID 6 tool used in the EU. The Ministry recently received €1.6 million for the project. According to the ministry, a tender process for the project is already underway for the project, which is expected to last six years. Six consortiums have been short-listed. 

The KKDIK Regulation requires companies to preregister chemicals by the end of 2020. The registration phase will run until 2023. 

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EU Prohibits Lead from PVC Products

The EU plans to supplement Annex XVII of REACH and has published the corresponding draft regulationWith the amendment, the EU forbids the use of lead and lead compounds in the manufacture of PVC articles. In addition, PVC articles may no longer be placed on the market when the concentration of lead in the material is equal to or exceeds 0.1% by weight. Exceptions apply for recycled rigid and flexible PVC materials and for PVC-silica separators in lead batteries.

Annex XVII of REACH lists chemicals or groups of chemicals that pose risks to human health and the environment, so that their manufacture, marketing (sale), or use is completely prohibited or is limited. The lead prohibition can be found at entry 63 in the list. With the prohibition, the EU follows recommendations made by the Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC).

Lead compounds are used as stabilizers in the manufacture of PVC because they protect the product from photodegradation. Since 2016, the PVC industry in the EU has voluntarily abstained from the use of lead stabilizers.

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Deadlines for Dossier Updates: Industry and Governments React to EU Proposal

Industry associations and EU member states consider the deadlines proposed by the EU for updates of registration dossiers unrealistic. They expressed this opinion in statements published after the CARACAL meeting at the beginning of July.

For example, Eurometaux, the European Association of Non-Ferrous Metals Producers and Recyclers, highlighted the complexity of the interconnections involved. It noted that every individual data record to be updated affects other criteria, such as classification and risk assessment. Accordingly, says Eurometaux, it is not simply a matter of creating a new compilation of data in the dossier, but of ensuring the consistency of data across several levels – between the IUCLID file and chemical safety reports.

Concerns about the deadlines were also expressed by SMEunited, an organization devoted to the interests of 12 million companies with about 50 million employees, mostly craftpersons, across Europe. SMEunited succeeded UEAPME (European Association of Craft, Small and Medium-Sized Enterprises) in November 2018. Representatives of  SMEunited regard the deadlines as too short because smaller companies generally outsource updates to service providers. To obtain additional time buffers, they therefore call for longer deadlines, specifically a change from one month to three months.

In its statement, the Finnish Safety and Chemicals Agency (TUKES) warned about unclear terminology. For example, the exact meaning of “monitoring and tracking systems,” as given in Article 2 of the planned implementing regulation, must be clarified. And the expression “a use no longer relevant” also needs an explanation. The leaders of the Finnish agency have also uncovered contradictions. For example, Article 1 allows six months for an update of the chemical safety report, but Article 6 of the same document allows only one month for an update.

The Irish Health and Safety Authority (HSA) is also irked by the formulation of Article 2 of the planned implementing regulation, which requires companies to provide “monitoring and tracking systems” that would allow them to identify any changes related to chemicals at all times. Article 36 of REACH states only that companies should “assemble and keep available all information.” According to the HSA, the phrase “monitoring and tracking systems” is a further development of the definition in REACH and therefore requires an explanation.

All objections and comments will be discussed at the next CARACAL meeting in November.

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Study Shows That GHS Classification Also Possible for Nanomaterials

In principle, GHS classification criteria are also applicable to nanomaterials. That’s the result of a study
financed by the Nordic Council of Ministers (consisting of representatives from Denmark, Finland, Iceland, Norway, and Sweden) and the Finnish Safety and Chemicals Agency (TUKES). A Danish water specialist, DHI, conducted the study and selected the following nanomaterials for its analysis:

  • Single-walled carbon nanotubes (SWCNT)
  • Nanosilicon dioxide
  • Nanosilver
  • Nanozinc oxide

The characteristics of the four chemicals differ in terms of their chemical composition, form, water solubility,
specific surface area, and density. Because toxicity depends on the physico-chemical properties of each substance, the choice of the four items ensured that the scope of their effects was covered adequately.

In recent years, the OECD Working Party on Manufactured Nanomaterials (WPMN) collected and published a large amount of data on engineered nanomaterials. Combined with other data on nanomaterials (NanoReg project, NanoSafety Cluster projects, and REACH Registrations), this information provided the foundation for the analysis.

Ultimately, the researchers concentrated on very specific data that aligned with specific hazard classes in the GHS:

  • Acute toxicity: All four nanomaterials
  • Specific Target Organ Toxicity, Repeated Exposure (STOT RE): All four nanomaterials
  • Eye irritation: SWCNTs
  • Germ cell mutagenicity: SWCNTs
  • Skin sensitization: Nanosilver

Most of the data could be classified without the limitations of the GHS. For information on the chemicals and criteria that had limitations, how the experiments were performed, and the results of individual experiments, see the 107-page report on the study.

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