From Italy to India: a Critical Analysis of India's Draft Regulation of 'Forever Chemicals'

Introduction

On 26 June 2025, the Court of Assize in Vicenza, Italy, delivered a landmark judgment as the Court convicted eleven former executives of Miteni S.p.A., for their role in decades long PFAS (Per- and Polyfluoroalkyl Substances) contamination. The company was responsible for contaminating one of Europe's largest groundwater aquifers, resulting in PFAS-contaminated drinking water that exposed more than 350,000 residents in the Veneto region to these hazardous chemicals and adversely affected their health.  

In a recent development, the manufacturing equipment of the decommissioned Italian plant was acquired by an Indian company and was relocated to Mumbai, where production of PFAS compounds subsequently resumed. This development highlights significant concerns regarding the regulation of PFAS in India, particularly in the absence of a dedicated legal framework, at a time when jurisdictions across the world are adopting increasingly stringent measures to limit human exposure to these chemicals.

PFAS are a group of toxic chemicals which are highly resistant to biodegradation. These chemicals are used in different industries such as aeronautics, electronics, food packaging, food processing, firefighting, cosmetics, etc. Because of their widespread use and their persistence in the environment, PFAS are found in various environmental matrices such as in air, surface water, ground water, etc. People usually get exposed to these chemicals through air, water, food, and by using the products made from these chemicals. Because of their abundance and the public health concerns associated with them, it is important to regulate their use.

In India, there is no dedicated regulation to comprehensively govern the use of PFAS. However, as a positive step in this direction, on 6 October 2025, the Food Safety and Standards Authority of India (FSSAI) has published a draft notification proposing amendments to the Food Safety and Standards (Packaging) Regulations, 2018, which focuses on the prohibition of the use of PFAS in food contact materials (FCMs). This blog examines the draft notification, its implications and the extent to which it addresses the public health challenges posed by PFAS in India.

PFAs and the Implications of their Use in Food Contact Materials

PFAS are a group of over 12,000 synthetic chemicals characterised by a chain of linked carbon and fluorine atoms, whose stable bond structure results in long-term environmental persistence. Unlike other toxins that degrade, PFAS bioaccumulate in the human body. Due to their resistance to biodegradation and the tendency to persist in the environment for years, they are also referred to as “Forever Chemicals”.

In the past few decades, PFAS use in FCMs, including fast-food wrappers, disposable food containers, and microwave popcorn bags, owing to their exceptional grease-, oil-, and water-resistant properties, which help prevent the seepage of food and liquids, has increased. Studies have shown that PFAS in FCMs can migrate into food, thereby increasing dietary exposure and raising serious public health concerns such as the increased risk of cancer, hypertension, liver damage, thyroid disease, asthma, complications in pregnancy, decreased fertility etc.

Regulatory Gap in the Governance of PFAs in India

The Stockholm Convention is the principal international treaty regulating certain PFAS. The Convention classifies hazardous chemicals into three annexes, requiring Parties to eliminate (Annex A), restrict (Annex B), or minimise (Annex C) their production, use, and release. It has included PFOS, PFOA, and PFHxS, which belong to the family of PFAS compounds within its list of regulated substances. India, being a party to the Convention, is obligated to take steps to eliminate, restrict or minimise the production, use, import and export of Persistent Organic Pollutants.

Article 21 of the Constitution of India has been interpreted by the Courts to include the right to healthy environment. Thus, the Government is constitutionally obligated to take effective measures to regulate hazardous substances, including chemicals that pose significant risks to human health and the environment.  Furthermore, Article 47 of the Indian Constitution mandates the State to regard the improvement of public health as among its primary duties.

Relevant to this discussion is the Precautionary Principle, recognised by the Supreme Court in Vellore Citizens Welfare Forum v. Union of India, which requires regulatory authorities to take preventive action where there are credible threats of serious or irreversible environmental harm, even in the absence of conclusive scientific certainty. Given the growing scientific evidence on the adverse health effects of PFAS, the State has the obligation to regulate these substances to minimise human exposure to them.

Hence, India is obligated, both under its international commitments and the constitutional mandate, to regulate PFAS. While a comprehensive legal regime remains absent, the FSSAI draft amendment marks a positive regulatory intervention towards addressing PFAS exposure.

Analysis of the Draft Amendment

The draft amendment inserts the following sub-regulations into Regulation 3 of the Food Safety and Standards (Packaging) Regulations, 2018:

“Poly- and perfluoroalkyl substances (PFAS) shall not be used in the manufacturing of food contact materials.”

Firstly, the draft notification does not define PFAS, nor does any existing Indian statute or legislation provide a legal definition of the term, which creates uncertainty regarding their scope. Moreover, the absence of a universally accepted definition at the international level increases the uncertainty. While scientists and organisations such as the OECD generally describe PFAS as fluorinated substances containing at least one fully fluorinated methyl or methylene carbon atom, governments across jurisdictions have adopted different working definitions depending on their regulatory objectives. The lack of a clear statutory definition may therefore create ambiguity regarding the precise range of substances intended to be regulated under the draft notification.

Secondly, the draft notification provides that PFAS “shall not be used” in manufacturing FCMs. While this clearly prohibits the intentional use of PFAS, it remains silent on the treatment of non-intentionally added PFAS (NIAS). Studies have shown that PFAS may be unintentionally present in FCMs due to cross-contamination from manufacturing equipment or the use of recycled paper and wood pulp containing residual PFAS. The draft notification does not clarify whether the prohibition extends to such unintentional contamination or is confined solely to the deliberate addition of PFAS during manufacturing, creating uncertainty regarding the scope of manufacturer’s compliance obligations of the proposed regulation.

Lastly, although thousands of PFAS have been identified, existing analytical methods are capable of detecting and quantifying only a limited number of them. This presents a significant practical challenge to the implementation and enforcement of the proposed prohibition, as the presence of many PFAS may remain undetected. Comparative Perspective

To evaluate the Indian proposal, it is useful to compare it with regulations in other jurisdictions.

FSSAI’s draft notification bans the use of PFAS however does not define them. In contrast, the proposed restriction under the European Union's REACH Regulation adopts a class-based definition, identifying PFAS as substances containing at least one fully fluorinated methyl (–CF₃) or methylene (–CF₂–) carbon atom without any H/Cl/Br/I attached to it. Likewise, several U.S. states have incorporated statutory definitions into their legislation. For example, the State of Maine defines PFAS as fluorinated organic chemicals containing at least one fully fluorinated carbon atom. These approaches enhance legal certainty by clearly identifying the substances intended to be regulated.

Moreover, the draft notification merely provides that PFAS “shall not be used..”, without making a distinction between intentionally added PFAS and NIAS. The regulatory approach opted by Denmark is useful here, as it clearly prohibits intentional use of PFAS in the paper and board food-contact material. Moreover, to distinguish intentional addition of PFAS from NIAS, the Government established a threshold of 20 μg of organic fluorine per gram of paper i.e; if the fluorine content is below 20 μg of organic fluorine per gram of paper, then it will be treated as unintentional background contamination of PFAS, while above this value the manufacturer has to show that it is not intentionally added. If the unavoidability of contamination is shown by the manufacturer, then the law allows the use of such FCMs on the condition that a functional barrier to prevent migration into food is provided. In addition, proper implementation of the FSSAI’s amendment is also hurdled by the absence of an effective method to detect all members of the PFAS family.  Denmark’s approach of using an indicator value based on total fluorine may provide an objective criterion for regulatory enforcement.

Conclusion and Suggestions

The relocation of the former Miteni plant’s equipment from Italy to India underscores that PFAS regulation is no longer a matter of future concern but an immediate regulatory priority. In the absence of a comprehensive legal framework governing PFAS, the FSSAI's draft notification represents a significant and commendable step towards reducing public exposure to these persistent chemicals through food-contact materials. Nevertheless, the effectiveness of the proposed framework can be strengthened by: (i) expressly defining PFAS; (ii) clarifying whether the prohibition extends to non-intentionally added PFAS; and (iii) prescribing appropriate analytical standards and implementation guidelines to facilitate effective compliance and enforcement. As India moves towards regulating "forever chemicals," a clear, scientifically informed, and enforceable framework will be essential to safeguarding both public health and the environment.