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September 18, 2019

EC Proposes REACH Restriction For PVC Articles Containing Lead And Lead Compounds and Other Recent REACH Developments

Bergeson & Campbell, P.C.

EC Study To Analyze Integration Of REACH In Customs Procedures: The European Commission (EC) will launch a “call for tender” in relation to Action 13 of the Second Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Review, which addresses enhancement of enforcement. In a document entitled “REACH and customs contract” issued following the 30th Meeting of the Competent Authorities for REACH and Classification, Labeling, and Packaging (CLP) (CARACAL), the EC indicates that “[s]trengthening the enforcement of the obligations on all actors, including registrants, downstream users and in particular [importers], is necessary to ensure a level playing field, meet the objectives of REACH and ensure consistency.”

As part of its goal under Action 13 of the Second REACH Review to “clarify and enhance” the role of enforcement and customs authorities in the enforcement of REACH, the EC will contract a study to analyze integration of REACH into customs procedures. The EC indicates that the main purpose of the study contract will be to elaborate a set of options and tools to further support the integration of REACH provisions into “Customs legislation/procedures.” The feasibility of the various options will be evaluated by the EC, and the “length of the contract shall be 16 months.”

The EC provides that the following “tasks are required to be performed in the contract”: (1) identify and review relevant information (e.g., REACH and customs legislation, enforcement projects, “ways of cooperation among REACH and customs authorities”); (2) identify REACH provisions and activities “that may be integrated in customs”; (3) develop procedures for each topic identified in task 2 and draft interlinks, classify and select clusters of activities, develop summary fact sheets; (4) discuss the preliminary results in an “ad-hoc Workshop”; and (5) elaborate the final report.

Cefic Offers Feedback On Implementing Regulation Regarding Duty To Update Dossiers: The European Chemical Industry Council (Cefic) issued a memorandum entitled “Cefic’s feedback on a draft Implementing Regulation on duty to update dossiers.” In its memorandum, Cefic indicates that REACH Article 22(1) defines cases when an update of a REACH registration dossier is needed. Cefic provides that it is fully behind the EC’s initiative, which seeks to clarify, via an Implementing Regulation, “how the provisions of article 22(1) should be understood.”

Cefic states “[a]ll actors involved will benefit from having a clearer understanding of the different elements of art. 22(1).” Cefic indicates that, at the CARACAL meeting of November 21-22, 2018, the EC presented time frames “clarifying the notice ‘without undue delay.’” Cefic states that it “fully supported this proposal” and that significantly revised time frames were presented at the July 1-2, 2019, CARACAL meeting. Cefic indicates the “[l]atest timeframes would be extremely challenging to meet,” stating that they merely seem to fit easy, straightforward updates of dossiers.

Cefic provides that, in reality, such “updates are rather exceptional” and typically complex, “simultaneous touching upon different elements and/or involving multiple actors.” In its memorandum, Cefic suggests alternative time frames for updating dossiers under REACH, indicating that it is convinced its proposal “strikes the right balance between workability and securing timely updates of dossiers.” Cefic also suggests “a few additional changes to avoid introducing a new layer of uncertainties via the implementing regulation.”

Cefic’s suggestions include a six-month time frame for updates in case of changes in a registrant’s status or identity, no mandatory update “in case a lower threshold is reached,” and an update requirement six months after receiving the final required test report in case “a higher tonnage band is reached.”

EC Proposes REACH Restriction For PVC Articles Containing Lead And Lead Compounds: On July 12, 2019, the EC notified WTO of a draft regulation and related Annex that would amend Entry 63 to REACH Annex XVII. The proposal from the EC “would prohibit the use of lead and lead compounds in articles produced from [polymers or copolymers of vinyl chloride (PVC)] as well as their placing on the market in articles produced from PVC if the concentration of lead (expressed as metal) is equal to or greater than [0.1 percent] by weight of the PVC material.” Time-limited exemptions from this limit are provided for rigid and flexible recycled PVC material and PVC-silica separators in lead acid batteries.

The “objective and rationale” section of the WTO notification states “[t]o reduce releases of lead during the service life of PVC articles thereby contributing to reducing direct and indirect exposure to lead, a toxic metal.” The European Chemicals Agency’s (ECHA) Committee for Risk Assessment (RAC) adopted its opinion on the proposed restriction in 2017, concluding that the proposal is “the most appropriate Union-wide measure to address the identified risks posed by lead compounds present as stabilisers in PVC articles in terms of effectiveness in reducing such risks, practicality and monitorability.” ECHA’s Committee for Socio-economic Analysis (SEAC) concluded that the proposed restriction, as modified by RAC and SEAC, is the most appropriate “Union-wide” measure to address the identified risk, in terms of its socioeconomic benefits and costs.

Comments on the proposed restriction were due “60 days from notification” to WTO, and the proposed date of adoption is the “3rd quarter of 2019.” The proposed date for entry into force of the restriction is 20 days from publication in the Official Journal of the EU. Application of the restriction on the placing on the market of articles would be deferred for 24 months after its entry into force.

RoHS 3 Restrictions For Four Phthalates Enter Into Force: An amended version of the Restriction of Hazardous Substances Directive (RoHS 3) entered into force in 2015, and the revised Annex II restrictions have applied since July 22, 2019. RoHS 3 includes in Annex II the following phthalates, with corresponding “maximum concentration values tolerated by weight in homogeneous materials”: (1) bis(2-ethylhexyl) phthalate (DEHP) — 0.1 percent; (2) butyl benzyl phthalate (BBP) — 0.1 percent; (3) dibutyl phthalate (DBP) — 0.1 percent; and (4) diisobutyl phthalate (DIBP) — 0.1 percent.

Since July 22, 2019, electrical and electronic equipment (EEE) containing the phthalates above specified concentration limits cannot be sold on the EU market. RoHS 3 includes the following exemptions:

  • The restriction of DEHP, BBP, DBP, and DIBP shall apply to medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, from July 22, 2021.
  • The restriction of DEHP, BBP, DBP, and DIBP shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities, or upgrading of capacity of EEE placed on the market before July 22, 2019, and of medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, placed on the market before July 22, 2021.

ECHA Addresses Public Concerns Regarding Intentionally Added Microplastics Restriction Proposal: On July 25, 2019, ECHA issued a press release entitled “Restriction proposal for intentionally added microplastics in the EU — update.” In its press release, ECHA indicates that “[s]everal media have recently reported that proposals to restrict the intentional use of microplastics under the REACH regulation will result in the closure of thousands of artificial turf pitches across the EU.”

ECHA states that the granular infill material typically used in artificial turf pitches is understood to be an “intentionally-added microplastic,” but neither ECHA nor the EC are proposing that these pitches should be closed. ECHA states that it was requested by the EC in 2018 to prepare a restriction proposal for intentionally added microplastics under the REACH regulation, and “[t]his is done in the wider context of the EU plastics strategy.” ECHA published its proposal in March 2019, and opened a public consultation that closes on September 20, 2019.

ECHA provides that the restriction proposal addresses a wide range of uses of intentionally added microplastics. ECHA states “further information has been requested on the use of granular infill material in synthetic turf in order to assess the implications and the possible need for a derogation.” ECHA indicates that as “[t]hese pitches are a substantial source of microplastics to the environment,” it is gathering information on the socioeconomic impacts of phasing out microplastic infill material.

ECHA provides that it is also gathering information on the effectiveness of technical measures to prevent the loss of infill material from artificial turf pitches into the environment. ECHA’s RAC and SEAC will review the information received “as they consider their opinions on the restriction proposal.” ECHA provides that the Committees’ final opinions are expected in early 2020, after which they will be sent to the EC for decision making.

ECHA states that all factors, including the important role that sports fields play in promoting physical exercise, health, and social inclusion, are taken into account in the decision-making process.

ZWE Publishes Study On Chemical Recycling, Offers Policy Recommendations To Ensure Chemical Recycling Complements Circular Economy: On August 29, 2019, Zero Waste Europe (ZWE) announced the availability of a study on chemical recycling that examines the state of implementation of the technologies in the European context. The study notes that plastic cannot be “endlessly mechanically recycled” without reducing its properties and quality, and not all types can be mechanically recycled. ZWE states that chemical recycling “could be a complementary solution to mechanical recycling where the latter is unsuited to materially recover plastic because it is too degraded, contaminated or too complex. On the flipside, it could also become the new plastics El Dorado if plastic to fuels is allowed.” The study emphasizes the importance of establishing a policy frame work to accommodate chemical recycling as complementary to mechanical recycling and to ensure that carbon stays in the plastic and is not released into the environment. ZWE offers policy recommendations intended to ensure that chemical recycling complements a “real” circular economy:

  • Chemical recycling should be defined to exclude any operation that does not result in the production of new plastic;
  • Only processes with a lower carbon footprint than the production of plastic from virgin feedstock can be classified as chemical recycling;
  • Chemical recycling should be used to deal with degraded and contaminated plastics and never with plastics coming from separate collection;
  • Verification systems should be established to ensure chemical recycling process outputs plastic and plastic feedstocks; facilities licensed for chemical recycling should not produce fuel as primary output;
  • To avoid competition with mechanical recycling, but also to differentiate from recovery and disposal operations, a new level in the waste hierarchy should be added for those operations that recover materials from mixed waste that today would be burned or landfilled; and
  • For coherence with the EU Climate and Circular Economy agendas, EU funding should only be allowed to finance plastic to plastic chemical operations.

ECHA Will Hold Biocides Day On October 29: ECHA will hold its annual Biocides Day on October 29, 2019, at its offices in Helsinki, Finland. Biocides Day will focus on active substance approval, endocrine disruptors, and biocidal product families. To attend in person, registration is required. ECHA will also stream it online. The conference is open to all, but according to ECHA will be particularly useful for companies, industry associations, public bodies, non-governmental organizations, and research institutions involved in biocides.