Overview
1. The European Commission’s Strategy for Plastics
In January 2018, the European Commission adopted the so-called European Strategy for Plastics in a Circular Economy (or ‘Plastics Strategy’) to address the entire lifecycle of plastic products: from design and manufacture, to use and recycling.
The overall objective of the strategy is advancing the transition towards a circular economy, improving competitiveness of the European plastics industry and contributing to reaching the EU’s international commitments for the environment.
The strategy envisions a set of EU measures pursuing four main purposes:
- Improving the economics and quality of plastics recycling;
- Curbing plastic waste and littering;
- Driving investment and innovation towards circular solutions;
- Harnessing global action.
What Is Going to Change?
The strategy intends to impact the existing EU legislation horizontally. The regulatory frameworks to be amended or revised include packaging and packaging waste, eco-design, construction products, end-of-life vehicles, food contact materials, quality standards, Ecolabel and ‘green procurement.’
Plastic waste will be tackled through monitoring and mapping initiatives. Possible regulation will address single-use plastics, ships waste, plastic loss from aquaculture, marine litter, or oxo-degradable plastics and microplastics (both when intentionally added and when unintentionally released).
Who Is Going to Act?
The strategy sets out a series of measures to be considered both at the EU and the national level.
Industry is encouraged to pursue voluntary commitments and seize the opportunity for research and investment, in particular in the areas of recycling, waste management and development of alternatives to single-use plastics.
Focus on the Interface Between Chemical, Product and Waste Legislation
The Commission has identified four issues which require a consistent approach coordinated across different legislations:
- Information on presence of substances of concern
The Commission finds that lack of information on the presence of substances of concern in products and waste hinders the transition from waste to product. In particular, availability of information on the composition of a product appears to decrease during its lifecycle. The Commission intends to make a larger use of the Restriction procedure under the REACH Regulation, while also simplifying the procedures to restrict the use of CMR substances in consumer products. - Legacy substances
Substances of concern may be present as constituents or impurities in recovered materials. When their presence is detected, these substances may influence the classification and the placing on the market of a material. By so doing, materials containing substances of concern may become unsuitable for further use and recycling, unless they are properly treated. The Commission intends to address the risks linked to the presence of substances of concern in secondary raw materials, via the publication of guidelines and, possibly, ad hoc implementing legislation. - End-of-waste criteria
The Waste Framework Directive (Dir. 2008/98/EC) establishes general criteria to determine when waste ceases to be waste, but implementation and application of those criteria are different among Member States. The Commission intends to address the uncertainty caused by this lack of harmonization via the set-up of a repository of all EU and national measures laying down criteria for determining criteria for end-of-waste and by-products. - Classification of waste
The lack of harmonization and consistency in the application and enforcement of the rules for classification of waste have an impact on collection, management and recycling of waste. The Commission committed to publishing guidance to help operators and national authorities adopt a common and consistent approach to waste classification.
2. Amendment of the General Food Law Regulation and Transparency in EFSA Risk Assessment
The European Commission (DG SANTE) has launched a public consultation on the transparency and sustainability of the EU risk assessment in the food chain, by which interested third parties may submit comments and respond to a questionnaire until March 20, 2018. The main target areas of the questionnaire are:
- Transparency and independence of studies;
- Evidence from industry studies;
- Risk communication in the agri-food chain; and
- Sustainability of the risk assessment system and involvement of Member States.
The focus on the interplay between confidentiality and transparency in EFSA’s risk assessment (whose opinions serve, for example, as a basis for science-based decision-making on plant protection products[1]) is unsurprising, since the consultation was triggered by the European Citizens’ Initiative (ECI) on Glyphosate[2] and the Fitness check on the General Food Law Regulation (GFL Regulation). The Fitness check was published by the European Commission on January 15, 2018 and found that “transparency of risk analysis remains an important issue in terms of perception.” It further considered that the strict confidentiality rules and the legal requirement to primarily base EFSA’s scientific assessment on industry studies “lead civil society to perceive a certain lack of transparency and independence, having a negative impact on the acceptability of EFSA's scientific work by the general public.” [3]
The consultation also includes questions related to steps aimed at increasing transparency, for instance by focusing on the format, timing and type of data that should be made available.
The questionnaire seems to indicate that the Commission continues[4] to consider that the current regime of confidentiality and disclosure of information might need adjustment. Moreover, the response options foreseen by the questionnaire of the consultation appear to indicate the “framework” within which the Commission considers to amend the GFL Regulation. Given the drastic nature of some of the provided options[5], and the potential impact on Confidential Business Information, comments to address potential negative effects of some of the outlined options are therefore essential.
Participation in the consultation exercise is crucial also since the results of the public consultation will directly feed into the legislative proposal to amend the GFL Regulation. Since the European Commission considers that "transparency in scientific assessments and decision-making is vital to ensuring trust in the regulatory system"[6] these and other aspects (such as the governance of EFSA) will be covered by a legislative proposal by the European Commission, scheduled for publication by May 2018.[7]
Data and transparency are also in the spotlight of the European Parliament: the Committee on the Environment, Public Health and Food Safety (ENVI), established a data working group to advocate for greater format harmonization of safety data held by the European Food Safety Authority (EFSA), the European Chemicals Agency (ECHA) and the European Medicines Agency (EMA) and assessing, amongst others, how to create greater public transparency and a level playing field for industry.[8] The working group is scheduled to meet quarterly, and suggest that the approach taken regarding EFSA is likely to spread to other EU agencies.
3. Data Sharing for 2018 Registration – Free Data Access for SMEs?
In view of the upcoming 2018 registration deadline, in October 2017 ECHA had proposed granting free data access to SMEs as a “pragmatic way forward” to allow SMEs to register with minimum efforts.[9] The initiative was driven by the results of an ECHA-commissioned study which outlined the difficulties SMEs encountered with their REACH Registrations.[10]
The proposal was met with concerns as to its legality under the REACH Regulation and Commission Implementing Regulation (EU) 2016/9 and, in particular, the principles of fairness, transparency and non-discrimination which govern the sharing of costs associated with data and joint submission.
In response to ECHA’s proposal of October 2017, the Directors’ Contact Group issued its “Recommendation to help small volume and SME registrants in registering for the 2018 REACH Registration Deadline” on December 15, 2017, not taking up ECHA’s proposal of free data access for SMEs. Nonetheless, the DCG acknowledged the difficulties of SMEs (costs of data/studies, lack of experience, complexity of data sharing agreements, difficulties in starting data sharing disputes) and therefore recommends four alternative actions to assist low volume and SME registrants:
- Reducing costs for 1-10 tons, low volume registrants through “thoroughly exploring data waiving arguments”
The DCG recommends reviewing whether the submission of data is actually required by the registrant or whether data waiving arguments may be applicable under the exemptions for low tonnage bands, provided for in Article 12 (a-b) of REACH. SME registrants remain responsible for this “thorough exploration” of data waiving arguments under Article 12 and “[w]herever data requirements can be waived on this basis.”[11] In particular in case of first registrations, this requires considerable expertise (such as QSAR and read-across) which SMEs might lack. - Addressing consequences of late data-sharing negotiations or pending data-sharing disputes
The DCG considers that new registrants and SMEs are likely to find themselves in late data sharing negotiations (close to the registration deadline) and may be less aware of ECHA’s data sharing dispute mechanism. Currently, data access is not granted as long as the data sharing dispute is pending before ECHA. It is only once ECHA takes a decision in favor of the data accessor that access is granted and that the data accessor may legitimately rely on the data. The Agency’s data sharing decisions taken under Articles 27, 30 (2) and 30(3) of REACH may be appealed within three months by either party (Article 92(1-2) of REACH). Such an appeal has suspensive effect (Article 91(2) of REACH), meaning that ECHA’s data sharing decision is suspended, pending the outcome of the appeal. - Allowing payment by installments
In cases the payment of data costs would constitute an unaffordable financial burden on the SME, the lead registrant/SIEF managers are recommended – voluntarily – to consider allowing the staged payment to facilitate their registration. - Allowing lump sum payments
Likewise, lead registrants/SIEF managers could offer the payment of a lump-sum tosmall-volume registrants in the 1-10 tonnage range as a voluntary courtesy. According to the DCG recommendation such lump sum payment would reduce the administrative burden (including setting up a reimbursement scheme) and reduce the risk of a data sharing dispute. However, allowing lump-sum payments only to certain (SME) registrants may raise claims regarding fairness and non-discrimination by other (non-SME) registrants. Lead registrants/SIEFs therefore ought to carefully examine their established data sharing rules and seek the agreement of the other co-registrants, prior to agreeing to such payments.
Uncertainties as to the legal value and practical application of the recommendations remain: data owners may be hesitant to agree to lump-sum payments or payment by installments, as this could potentially expose the cost sharing to claims of discrimination.
This, at the very least, unconventional, approach to 2018 registrations by SMEs has been further manifested by the Agency’s recent announcement to “help” registrants who fail to meet the registration deadline in four scenarios (see pervious Steptoe alert Failure to Meet the 2018 REACH Registration Deadline: Directors’ Contact Group Announces “Help” in Four Scenarios and Adds Uncertainty).
Data sharing under REACH, in particular in view of the upcoming 2018 deadline, will also be addressed at the Chemical Watch Webinar on “REACH 2018: Last Mile of Data Sharing Negotiations”on March 28, 2018 at 3:00 pm CET.
[1] See: Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, recital 12, Articles 21,23,38, 49.
[2] Communication from the Commission on the European Citizens' Initiative "Ban glyphosate and protect people and the environment from toxic pesticides", dated 12.12.2017, C(2017)8414.
[3] Executive summary: https://ec.europa.eu/food/sites/food/files/gfl_fitc_executive_summary_2018_en.pd
Full : https://ec.europa.eu/food/sites/food/files/gfl_fitc_comm_staff_work_doc_2018_part1_en.pdf
[4] Communication from the Commission, C(2017)8414, page 11: “Addressing a perceived lack of transparency may require an adjustment of certain procedures while continuing to ensure the legitimate balance between the interests of stakeholders wanting a maximum of transparency and the protection of legitimate business secrets of applicants in authorisation proceedings before EFSA.”
[5] See:
Question 2.2. “What impact would the publication of industry studies (including raw/aggregated data) used in EU risk assessment, with the exception of business secrets or other confidential information (in particular information about undertakings, their business relations or their cost components) have on the following objectives?”
Question 2.3 “What impact would the different possible timings for the publication of industry studies have on the transparency of the EU risk assessment system?”
Answer option 1: “Immediate publication of the parts of the industry studies identified by the industry as non-confidential at the beginning of the EU risk assessment process, before a decision has been taken on the validity of the confidentiality claims, if any, and before EFSA's opinion.”
Question 2.5 “If industry studies used in EU risk assessment were to be published with the exception of confidential data, how useful would the following tools/procedures be?”
Answer option 2: “Studies in publishable and machine readable formats”
[6] Communication from the Commission on the European Citizens' Initiative "Ban glyphosate and protect people and the environment from toxic pesticides", dated 12.12.2017, C(2017)8414, to be found at: https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_glyphosate_eci_final.pdf
[7] European Commission Roadmap Transparency and sustainability of the EU risk assessment model in the food chain
[8] http://www.europarl.europa.eu/news/en/press-room/20180124IPR92925/eu-agencies-data-harmonization-envi-working-group-launched
[9] http://files.chemicalwatch.com/Data%20sharing%20cost%20SME.pdf [file does not appear publicly available – only via chemical watch]
[10] Segmentation of potential SME Market for ECHA Cloud Services for REACH Registration, Final Segmentation report prepared for ECHA, 4 August 2017, RPA – Risk & Policy Analysts.
[11] “Recommendation to help small volume and SME registrants in registering for the 2018 REACH Registration Deadline”, page 1-2.
