The meeting

Not only Pfas: the EU debate on chemical safety rules

At the event organised by the ECR Group in the European Parliament, the European Chemicals Agency, the Commission and industry discuss how to reconcile health, innovation and competitiveness

by Angelica Migliorisi

6' min read

Translated by AI
Versione italiana

6' min read

Translated by AI
Versione italiana

There is a crucial game for the future of Europe, one that decides how much room to give to innovation, how much to the protection of health and the environment and how much to industrial competitiveness. A balance that appeared more fragile than ever in Brussels, at the headquarters of the European Parliament, when on 14 October a debate between ECHA - the European Chemicals Agency - the European Commission and industry representatives, entitled "Regulation, Safety and Competitiveness: ECHA's role in European industry and environment", was staged by the European Conservatives and Reformists Group (ECR).

ECHA: a technical referee in a political field

"ECHA is not a legislator, but a centre of scientific expertise,' Sharon McGuinness, the Agency's Executive Director, made it clear from the outset. Its task is to enforce European rules on chemicals, ensuring that every product placed on the market is assessed and managed in a safe manner. We want enforceable, science-based and predictable laws. We don't need more rules, we need better rules, she pointed out. She then hinted at a paradigm shift: more transparency, more digitalisation and risk assessment integrating new artificial intelligence tools. The aim must be to simplify without weakening: 'Simplification does not mean cutting protection, but making the system more effective for citizens and businesses.

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The REACH node: protection yes, but no paralysis

The Regulation REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the backbone of Europe's chemical policy. It requires those who manufacture or import chemicals to register them and demonstrate their safety. It is considered a model in the world, but also a regulatory maze for companies, so much so that the European Commission has intervened by setting the publication of the proposed major changes in order to simplify, modernise and strengthen enforcement.

MEP Petro Fiocchi (ECR), the European Parliament's contact person with ECHA and host of the meeting, issued a clear warning: 'Simplification must not mean banning more. We must make the rules more understandable and ensure that those who abide by the rules are not penalised'. Fiocchi went on to underline a real risk: 'If we ban a substance in Europe but then import products that contain it, we are only shifting pollution, not reducing it'.

On the industrial side, the president of Federchimica, Francesco Buzzella, recognised the value of the REACH Regulation, but denounced the growing administrative impact: 'The complexity of the system shifts resources from research to bureaucracy. Small and medium-sized enterprises are the most affected: we must lighten the burden and introduce serious economic impact analyses'. There is one principle on which Buzzella insisted: risk must be assessed in its context, not in the abstract. In other words, 'we need an approach based on real risk, not just on potential danger'.

McGuinness responded by emphasising that for ECHA, too, 'the quality of dossiers is a top priority: too many registrations remain incomplete or inconsistent. This is why the Agency is pushing for a principle of 'one substance, one assessment', i.e. a single assessment for each substance, shared by all authorities, to reduce duplication and time.

CLP: the common language of risk

Il secondo pilastro della regolazione europea in materia chimica è il Regolamento CLP (Classification, Labelling and Packaging). Stabilisce come classificare le sostanze pericolose e come comunicarne i rischi attraverso etichette e simboli standardizzati. Serve per garantire che in tutti i Paesi europei una sostanza tossica, infiammabile o cancerogena sia riconosciuta allo stesso modo. Attualmente sono in corso valutazioni per modificare la classificazione di alcune sostanze molto comuni, come etanolo, litio e talco, con l’ipotesi di inserirle tra i composti cancerogeni o mutageni. Le conseguenze però - spiegano alcuni speaker- potrebbero andare ben oltre il settore chimico e inficiare non solo ambiti sensibili come sanità e cosmetica, ma anche l’industria farmaceutica, i prodotti per l’igiene e numerose catene produttive europee.

Hans Ingels, Head of Unit DG GROW - Bioeconomy, Chemicals and Cosmetics, called the CLP Regulation 'a mammoth text, but indispensable for the single market'. But he also referred to a package of 'concrete simplifications' to reduce costs and time by introducing clearer criteria and new hazard classes, such as endocrine disruptors or substances persistent in the environment.

On the operational side, Mike Rasenberg, Director for Hazard Assessment ECHA, explained how a harmonised classification comes about: 'Every proposal goes through an independent scientific committee (RAC), which evaluates the evidence and formulates a public opinion. It is science within a legal framework'.The risk, he admitted, is that the enormous workload turns the classification into a bottleneck. Resources and planning are needed.

From the Ministry of Health, Raffaella Perrone, Director of the Biocides and Cosmetics Office, brought Italy's experience in the evaluation of biocides, with a particular focus on ethanol: 'The process is two-level: first the active substance is evaluated, then the finished product. We follow OECD standards and ensure that dossiers are robust, transparent and traceable'. An approach that, she recalled, 'makes the supply chain safer but requires collaboration between companies and national authorities'.

PFAS: the most controversial case

The most heated moment of the debate came on the subject of PFAS, the perfluoroalkyl substances known for their resistance to water, heat and degradation. They can be found everywhere, from microchips to medical devices, from non-stick coatings to technical textiles. Precisely because they do not degrade, PFAS accumulate in the environment and in the human body, earning them the nickname 'eternal substances'.The process that could lead to their restriction officially began on 13 January 2023, when Denmark, Germany, the Netherlands, Norway and Sweden submitted a joint proposal for a restriction to the European Chemicals Agency.

Since March 2023, the technical assessments of ECHA's two scientific committees, the RAC (Committee for Risk Assessment) and SEAC (Committee for Socioeconomic Analysis), have been underway. Both are examining in detail the 14 areas envisaged in the initial PFAS restriction proposal, analysing their environmental, health and economic impacts. The public consultation has revealed eight additional areas of use, but these will not be examined specifically in order to meet the European Commission's deadline of the end of 2026, by which time all assessments must be concluded. The RAC and SEAC plan to complete their analyses by the end of the year, including cross-cutting aspects such as PFAS production and issues common to the different sectors.

On 20 August, an updated version of the proposal was published, which introduces a more flexible approach than a total ban: some permanent derogations for areas considered essential and temporary derogations with periodic review for those where technical alternatives exist. Only after RAC and SEAC have formulated their final opinions will the European Commission be able to present the final proposal, which will then be discussed and voted on by the REACH Committee.

Tommaso Dragani, amministratore delegato di Aspedia e già Direttore della struttura di ricerca “Epidemiologia Genetica e Farmacogenomica” della Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, ha sottolineato che «i PFAS non sono una sola sostanza, ma una famiglia di oltre 12.000 composti». Eppure, la proposta di restrizione li tratta come un blocco unico. «È un errore scientifico - ha sostenuto - perché alcuni PFAS vanno vietati subito, ma altri – come i fluoropolimeri usati in medicina o nell’energia – non sono bioaccessibili e possono essere gestiti in sicurezza». Dragani ha chiesto dunque di concentrare i divieti sugli usi “dispersivi”, come nei cosmetici o negli imballaggi, e di investire in tecniche di bonifica biologica: «Non serve un divieto totale: serve precisione scientifica».

From the industrial front, Jonathan Crozier, Head of Chemicals Policy & Environment Policy at BASF - one of the world's largest chemical companies, based in Germany - brought a concrete case to everyone's attention: 'Our Ludwigshafen site is a city within a city: ten square kilometres, 200 plants, 34,000 workers. Even those who do not produce PFAS need them: they are needed for pipes, gaskets and membranes'. For Crozier, a total ban would jeopardise the safety of plants and entire value chains, from pharmaceuticals to aerospace.

The European Commission, represented by Paul Speight, Head of Unit DG ENV - Safe and Sustainable Chemicals, acknowledged the complexity of the issue: 'PFAS contamination is widespread and worrying. But not all uses are equal. We need intelligent regulation, capable of distinguishing between essential use and abuse'. Speight anticipated that Brussels aims for a restriction by use, not an indiscriminate ban: 'Protecting health without stopping innovation is the right direction'.

Protection and industry must coexist

Pulling the strings of the debate was Jessica Rosewall. The European Commissioner for the Environment emphasised that there is no contradiction between protection, innovation and industry if we can build trust, and that the EU must talk about chemistry 'more often and louder' because that is where the green and technological transition is at stake: 'Without safe chemistry, there will be no sustainable economy'.

All the speakers, after all, said the same thing, albeit in different words: Europe must learn to protect without giving up producing. As McGuinness summarised, 'the challenge is not between health and industry, but between visions: do we want a Europe that imposes or a Europe that leads?'.

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