7 Annex: Detailed analysis of the examples
7.1 Restriction under REACH: examples of substitution
7.1.1 Example 1: Restriction of Bisphenol A in thermal paper
Restriction scope: Use of BPA (Bisphenol A, CAS-Nr. 80-05-7) in thermal paper (took effect on 2nd January 2020)
Dossier submitter: France (2014)
Decision: Commission decision in 2016 to restrict BPA in thermal paper in concentrations of 0.02 % or more by weight41
Initial trigger and Annex XV dossier: There have been many years of concern regarding BPA`s endocrine disrupting properties and effects on humans and wildlife. Following the identification of BPA as a compound toxic to reproduction and inclusion in the REACH Candidate List, France submitted a restriction dossier in 2014. The Annex XV dossier indicated a risk for workers (primarily cashiers) and consumers exposed to bisphenol A when handling thermal papers.
RAC opinion: RAC concluded in 2015 that the risk for consumers is adequately controlled but confirmed the risk for workers.42 Moreover, RAC noted that bisphenol S (BPS), the most likely substitute according to France, may have a toxicological profile similar to BPA and might cause similar adverse health effects. Therefore, ECHA was tasked to monitor the use of BPS in thermal paper.
Impact of REACH: Substitution was triggered following the adoption of the restriction: An ECHA survey from 2018 showed that BPA is being replaced by BPS (Bisphenol S, CAS-Nr. 80-09-1) in thermal paper already before the official entry into force of the restriction in January 2020.43 In March 2019 Belgium and ECHA hosted a workshop on alternatives for BPA in thermal paper.44 The workshop focused on the alternatives available, e.g. whether there are any suspected issues related to their safety and the challenges for the supply chain in adopting them.
Changes in monitoring trends: It is probably too early to evaluate the impact of this restriction in terms of human and environmental exposures. Also, in future it will be difficult to assess the specific contribution of this restriction as there are many other uses of BPA resulting in human and environment exposure.
41 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R2235&from=EN
42 https://echa.europa.eu/documents/10162/30eddda4-b27c-659e-d6d2-7b8ef02320a9
43 https://echa.europa.eu/de/-/bpa-being-replaced-by-bps-in-thermal-paper-echa-survey-finds
44 https://www.health.belgium.be/en/supply-chain-substitution-workshop-alternatives-bisphenol-thermal-paper
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Ideas for a stronger substitution support by REACH: The substitution incentive would be stronger if more uses were covered and also substances with equally concerning properties were included. If the restriction had addressed similar bisphenols in a group approach the substitution by e.g. BPS in thermal paper could have been prevented45,46
Current state of play: Currently BPA is still on the market for many applications and further restrictions are under investigation. Germany has submitted a CLH dossier to update the harmonised classification.47 Belgium has meanwhile started the classification process for identifying BPS as a substance toxic to reproduction48, while still continuing the CoRAP process.
Alternatives available: As ECHA states, alternative developers are available such as BPS Pergafast® 201 and D8.49 Given the uncertainties regarding the potentially harmful properties, ECHA recommends companies to also consider technologies and innovations that could remove the need for bisphenols, phenols or non-phenolic substances when developing thermal paper.
Lessons learnt: The restriction is effective in driving the replacement of BPA, but in many cases probably to similarly problematic substances, despite early indications from RAC during the opinion development. The scope is very narrow and further restrictions might be needed for other applications and exposure routes, as currently evaluated by UBA. Discussions of the supply chain actors for various alternatives are ongoing. Grouping approaches could be helpful (but not in all cases – hazardous properties of potential alternatives have to be flagged/considered early!)
7.1.2 Example 2: Restriction of PFOA and its salts
Restriction scope: Production, placing on the market and use of PFOA (Perfluorooctanoic acid, CAS-Nr. 335-67-1) and its salts and related substances (July 2020 effect date for production, transition periods for specific uses are detailed in the restriction50)
Dossier submitter: Germany and Norway (2014)
Decision: Commission restriction published in June 201751
Initial trigger and Annex XV dossier: For many years there have been concerns regarding the PBT properties and widespread use in applications, such as special finishing to textiles and paper to achieve water, grease, oil and/or dirt repellency. The first discussion on an EU restriction for PFOA already took place in 2006 in the context of the EU PFOS restriction. In 2013, PFOA was identified as a Substances of Very High Concern (SVHC) because of its
persistence, bioaccumulative and toxic property (PBT), and was included in the Candidate List.
In June 2017, over 10 years after the first EU discussion, the restriction on PFOA and its salts and related substances was published in the EU Official journal.
RAC and SEAC opinion: RAC proposed two different concentration limits: namely 25 ppb for PFOA and its salts and 1 000 ppb for one or a combination of PFOA-related substances, in other substances, mixtures or articles, reflecting the possible presence of unavoidable impurities and
45 https://www.chemtrust.org/wp-content/uploads/chemtrust-toxicsoup-mar-18.pdf
46 https://www.kemi.se/en/news-from-the-swedish-chemicals-agency/2017/new-report-37- bisphenols-may-be-endocrine-disruptors/
47 https://echa.europa.eu/de/registry-of-clh-intentions-until-outcome/-/dislist/details/0b0236e18280184f
48 https://echa.europa.eu/de/registry-of-clh-intentions-until-outcome/-/dislist/details/0b0236e182ed4414
49 https://newsletter.echa.europa.eu/home/-/newsletter/entry/moving-away-from-bpa-in-thermal-paper
50 https://echa.europa.eu/documents/10162/7a04b630-e00a-a9c5-bc85-0de793f6643c
51 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R1000&from=EN
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unintended contaminants, and taking account of the capabilities of analytical methods. SEAC agreed with the approach and with the exemptions proposed by RAC and suggested several referral periods to allow the sectors time for transitions. The restriction also exempts the unavoidable production of PFOA during the manufacture of fluorochemicals with a carbon chain equal to or shorter than six atoms. The concentration limits were criticized as too high by NGOs who also criticized the exemptions as being counterproductive to achieve a strong substitution trigger.52
Impact of REACH: Substitution was triggered following the announcement of the restriction and other substances were used instead of PFOA, mostly short chained PFAS. It can be assumed that also the process of listing PFOA under Stockholm convention will have added to this effect, as discussions have been going on for many years in parallel.
Changes in monitoring trends: It is still too early for a final judgement, but some research papers have found a slight decline in PFOS and PFOA in wildlife.53 On the other hand, levels of short-chain PFAS are on the rise. Moreover, the knowledge about impacts from aggregate exposures is increasing, which is currently neglected in the risk assessments of the individual substances, as highlighted by the RIVM.54
Ideas for a stronger substitution support by REACH: In order to trigger substitution at a larger scale, a broad restriction covering the whole group of PFAS chemicals was recommended (see below). Following the regulatory focus on PFOA, industry has moved to short chain
replacements like GenX and PFBS, both identified as SVHC in 2019. In addition, it would be desirable to consider combined effects from compounds in same groups to better protect environment and health. Research has highlighted known co-exposures of several PFAS substances to ecosystems and humans.55
Current state of play: In December 2019, the Netherlands have announced to consider a REACH restriction for all non-essential uses of PFAS.56 Meanwhile Germany has submitted a restriction proposal for undecafluorohexanoic acid (PFHxA), its salts and related substances.
Norway plans to restrict Perfluorohexane-1-sulphonic acid, its salts and related substances.
Lessons learnt: The PFOA restriction achieved a reduction of PFOA uses and applications, but the problem has now shifted to increasing exposure to short- chain PFAS. Discussions for a restriction of non-essential uses of the class of PFAS chemicals are ongoing at EU level. The development of a concept for only allowing `essential uses` could become an interesting new angle for triggering substitution efforts more efficiently.
7.1.3 Example 3: Restriction of four phthalates (DEHP, DBP, BBP and DIBP) in certain consumer articles
Restriction scope: Use of bis(2-ethylhexyl) phthalate (DEHP, CAS-Nr. 117-81-7), dibutyl phthalate (DBP, CAS-Nr. 84-74-2), benzyl butyl phthalate (BBP, CAS-Nr. 85-68-7) and diisobutyl phthalate (DIBP, CAS-Nr. 84-69-5) when present in any plasticised material in articles at a concentration, individually or in any combination, equal to or greater than 0,1 % by weight of any of such material.
52 EEB Report: Restricted success, 2017
53 CHEM Trust PFAS briefing, 2019, https://chemtrust.org/wp-content/uploads/PFAS_Brief_CHEMTrust_2019.pdf
54 https://www.rivm.nl/bibliotheek/rapporten/2018-0070.pdf
55 https://www.healthandenvironment.org/assets/images/Conley_1-15-2020_webinar_slides.pdf
56 https://www.endseurope.com/article/1669232/netherlands-working-proposal-ban-pfas-europe
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Dossier submitter: ECHA (in cooperation with Denmark), 2016
Decision: The restriction relating to DEHP, DBP, BBP and DIBP was published in December 2018.57 The Commission concluded that the four phthalates pose an unacceptable risk to human health when present in any plasticised material in articles at a concentration, individually or in any combination, equal to or greater than 0,1 % by weight of any of such material.
Initial trigger and Annex XV dossier: There had been longstanding concerns about endocrine disrupting and reprotoxic effects of these substances. All 4 phthalates are already on Annex XIV with a sunset date of 21 February 2015. The restriction dossier aims at restricting the use in relevant consumer articles. The dossier built on an earlier restriction proposal from Denmark from 2011. New human biomonitoring data from Democophes project supported the concern and became the basis for the joint restriction for 4 phthalates. RAC considered that a restriction related to the combined concentration of the four phthalates is needed to address the risk to human health.
Impact of REACH: While it is not easy to determine the exact trigger for substitution (in some case the classification or identification as SVHC, or the inclusion in Annex XIV) it was found that the use in certain phthalates dropped over the last years. This new restriction covers the gap also for the use of 4 phthalates in any plasticised material in articles.
Changes in monitoring trends: Although the use of certain phthalates have been replaced, the majority of the plasticizer`s market is still phthalates compounds, e.g. phthalates such as DINP, DPHP and DIDP are still produced in the EU and used in many applications. For example, DEHP is nowadays much less used in EU but in the rest of the world, DEHP continues to be the
dominant plasticizer (still 70% of global production).58 Human biomonitoring data for children in Germany showed decreasing trends for DEHP and other phthalates but an increase in other phthalates like DPHP (di-(2-propylheptyl) phthalate).59
Ideas for a stronger substitution support by REACH: The effectiveness of this restriction to trigger substitution could be increased by broadening the scope. They are at present not covered (despite the RA showing large exposure from diet)(Additional uptake of phthalates can origin from the food itself which can contain these substances60) This omission had been criticized by some NGOs as ineffective and incoherent as there will not be any subsequent substitution trigger for these phthalates in FCM. Current state of play: There are several other reprotoxic
phthalates on the REACH Candidate List and on Annex XIV.
Lessons learnt: Human biomonitoring data can be used to strengthen a restriction proposal, in particular when using a group approach to address combined exposures of similarly acting substances. The scope of the restriction proposal should include all significant exposure routes identified.
7.1.4 Example 4: Restriction of D4/D5 in rinse-off cosmetics
Restriction scope: Octamethylcyclotetrasiloxane (D4, CAS-Nr. 556-67-2) and
decamethylcyclopentasiloxane (D5, CAS-Nr. 541-02-6) in wash-off cosmetic products in a
57 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018R2005&from=EN
58 https://chemsec.org/app/uploads/2019/09/Replacing-Phthalates-%E2%80%93-ChemSec-190911.pdf
59 https://www.sciencedirect.com/science/article/pii/S1438463919306066
60 for details see
https://www.bfr.bund.de/de/presseinformation/2013/13/weichmacher_dehp_wird_hauptsaechlich_ueber_lebensmittel_aufgeno mmen-186791.html
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concentration equal to or greater than 0.1 % by weight of either substance, after 31 January 2020.61
Dossier submitter: UK (2015)
Decision: The Commission published the restriction in January 2018 following SEAC`s opinion that this is the appropriate Union-wide measure to reduce the discharge of D4 and D5 to wastewater in terms of its socioeconomic benefits and its socioeconomic costs
Initial trigger and Annex XV dossier: There have been long-standing concerns about
persistence and bioaccumulation about these substances. In March 2016 RAC concluded that D4 meets the REACH criteria as PBT and vPvB substance and that D5 fulfils the criteria for the identification of a vPvB substance. RAC confirmed that the hazard properties of D4 and D5 give rise to specific concerns for the environment when present in cosmetic products that are used or disposed of with water. It also concluded that the proposed restriction is a targeted and
appropriate Union-wide measure to minimize emissions caused by washed off products.
Impact of REACH: The regulatory discussions and restriction triggered substitution, as can be seen from advertisements for alternatives.62
Changes in monitoring trends: It is rather too early for a detailed assessment and little data are available. The silicone industry claims that recent monitoring data show decreasing trends of D4 and D5 in wastewater.63
Ideas for a stronger substitution support by REACH: The current restriction scope was very narrow in terms of substances and uses covered. Therefore, ECHA has started an additional restriction process.
Current state of play: In June 2018 D4, D5 and D6 (Dodecamethylcyclohexasiloxane, CAS-Nr.
541-02-6) were identified as SVHCs and included in the REACH Candidate List. Subsequently ECHA has proposed a restriction to restrict the placing on the market of D4, D5 and D6 as substances, as constituents of other substances, or in mixtures in a concentration equal to or greater than 0.1% w/w of each substance. The committee opinions are scheduled for March 2020.64
Lessons learnt: Important to avoid a too narrow scope of a restriction, otherwise additional restriction processes might be needed.