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Ask Our Experts: Our Most Popular Questions on Packaging and PFAS

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This blog was originally posted on 19th August, 2026. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

AUTHORED BY CATHERINE BURKE, SENIOR QUALITY ASSURANCE LEAD (REGULATORY CONTENT), ADHERENT


Keeping pace with the rapidly evolving landscape of product compliance can be challenging, particularly as new environmental and sustainability regulations continue to emerge across global markets. Our regulatory experts answered a wide range of questions from customers seeking practical guidance on some of today’s most significant compliance developments, including the EU Packaging and Packaging Waste Regulation (PPWR), and PFAS restrictions.  

This Ask Our Experts blog brings together the most frequently asked questions, offering practical insights into regulatory scope, compliance obligations, implementation timelines, and documentation requirements. Whether you are preparing for upcoming PPWR Declaration of Conformity requirements or assessing the impact of PFAS legislation, this blog highlights the key issues businesses are facing and the practical approaches our experts recommend. 

Table of Contents

Packaging

EU Packaging and Packaging Waste Regulation

Contents of Declaration of Conformity 

Although we cannot say for certain what would be included in the DoC for your company’s packaging, it is highly likely that a reference and/or description of the packaging materials would be included in the DoC.

According to Article 39(1) of the PPWR, the DoC “shall state that the fulfilment of the requirements laid down in or pursuant to Articles 5 to 12 has been demonstrated.” The format and content of the DoC is provided in Annex VIII to the PPWR. 

Annex VII states that the DoC must include a description of the packaging. This will likely include a reference to the packaging materials covered by the DoC.

Furthermore, the technical documentation, which accompanies the DoC, covers the assessment, the design, manufacture and operation of the packaging. According to Annex VII, this includes a general description of the packaging and the “conceptual design, manufacturing drawings and materials of components” of the packaging.

Single EU Declaration of Conformity 

A single declaration of conformity is required whenever a product is covered by several pieces of Union harmonisation legislation requiring an EU Declaration of Conformity. This process aims to reduce the administrative burden on economic operators.

Further details on this process are provided on page 62 of the EU’s Blue Guide, which is available here.

Essentially, in instances where a product is subject to DoC obligations from more than one piece of legislation the ‘single’ DoC should include references to all relevant Union harmonisation legislation complied with by the product.

Declaration of Conformity for Each Packaging Type 

According to Annex VII of the PPWR, a DoC is to be drafted for each “packaging type”. At the same time, page 41 of the recent FAQ document published by the Commission also states that “the assessment of conformity must be performed, and the declaration of conformity must be drawn up, for the entire packaging unit.”

The FAQ document may be accessed from here.

In relation to the meaning of a “packaging type”, Page 41 of the FAQ document states that the “packaging type” in Annex VII refers to “each packaging format or each packaging batch/series”.

A “packaging unit” is defined under Article 3 of the PPWR as “a unit, including any integrated or separate components, which as a whole serves a packaging function, such as the containment, protection, handling, delivery, storage, transport or presentation of products, and includes independent units of grouped or transport packaging where they are discarded prior to the point of sale”.

Page 43 of the above FAQ document states that “the declaration of conformity should be drafted at the level where packaging has the same characteristics in view of the applicable requirements and the packaged products”.

So, in my view, it is acceptable to prepare DoCs for an entire “packaging unit” and the same DoC may be used for other packaging units which are considered to be the same “packaging type” as the first unit.

On the other hand, if any of your packaging differs to an extent that they are considered to be different “packaging types” to one another (due to differences in their format, design or material composition for example), then they will each require a different DoC because once you have a different “type”, their compliance with the Regulation will be impacted due to the differences in the packaging’s characteristics.

Evidence/Data to Include in the Declaration of Conformity 

Firstly, it’s important to note that many of these Articles do not enter into force until a later date. So, on 12 August 2026, you need only demonstrate conformity with the requirements which actually apply from that date. I will go through each Article in turn.

Article 5

The following parts of Article 5 apply from 12th August: 

  • Article 5(1) states that packaging placed on the market shall be so manufactured that the presence and concentration of substances of concern as constituents of the packaging material or of any of the packaging components is minimised.
  • Article 5(4) states that the sum of the concentrations of lead, cadmium, mercury and hexavalent chromium resulting from substances present in packaging or packaging components shall not exceed 100 mg/kg.

Article 5(6) states that compliance with the Article 5(4) requirement above is to be demonstrated via the DoC and technical documentation per Annexes VII and VIII of the PPWR. This must be done from 12th August 2026.

Annex VII contains some basic requirements. It states that the manufacturer shall establish the technical documentation and shall cover, as far as relevant for the assessment, the design, manufacture and operation of the packaging.

Specifically, the following must be provided within the technical documentation, if applicable: 

  • A general description of the packaging and its intended use;
  • Conceptual design, manufacturing drawings and materials of components;
  • Descriptions and explanations necessary for the understanding of the drawings provided under point (b) and the schemes and operation of the packaging;
  • A list of:
    • The harmonised standards, referred to in Article 36, applied in full or in part;
    • The common specifications, referred to in Article 37, applied in full or in part;
    • Other relevant technical specifications used for measurement or calculation purposes;
    • In the event of partly applied harmonised standards or common specifications, an indication of the parts which have been applied;
    • In the event of harmonised standards or common specifications not being applied, a description of the solutions adopted to meet the requirements referred to in point 1;
  • A qualitative description of how the assessments provided for in Articles 6, 10 and 11 have been carried out; and
  • Test reports. 

Please note that the EU is yet to establish harmonised standards or common specifications that can be used to demonstrate conformity. 

For now, the only standards which have been officially recognised by the Commission as guidance to demonstrate conformity (at least until the adoption of new standards) under the PPWR are:

  • EN 13430:2004 (Article 6 on packaging recyclability)
  • EN 13432: 2000 (Article 9 on compostability)
  • EN 13428:2004 (Article 10 on packaging minimisation – However, this standard cannot be used to generate a presumption of conformity with Article 5 of the PPWR)

Article 6

This Article has various compliance deadlines, the earliest of which is likely to apply from 1 January 2030. Therefore, compliance with this Article need not be demonstrated by 12 August 2026.

Article 7

Again, this Article will not apply until 1 January 2030 at the earliest. Therefore, compliance with this Article need not be demonstrated by 12 August 2026.

Article 10 

Articles 10(1) and 10(2) do not apply until 1 January 2030. This is confirmed on page 24 of the recent FAQ document published by the EU Commission. 

Article 12

Relevant labelling requirements emanating from this Article do not apply until 12 August 2028 at the earliest.

Conclusion

So, from 12 August 2026, conformity need only be demonstrated with the Article 5 requirements which have been outlined above.

PFAS

Taiwan Controlled Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) and Their Operational Management Requirements

Status 

The regulation has not yet been finalized. However, the draft has been revised.

The key changes introduced in the revised draft include: 

  • The enforcement date has been postponed by one year, from 1 January 2026, to 1 January 2027.
  • A 24-month transition period will follow enforcement, allowing affected operators until 1 January 2029, to complete labeling, Safety Data Sheet (SDS) preparation, and obtain required operational approvals.
  • Recordkeeping obligations will be the only requirement taking effect immediately upon enforcement on 1 January 2027.
  • The number of proposed regulated PFAS substances has been reduced from 269 to 182 substances.
  • The regulatory concentration threshold has been increased from 0.1% w/w to 1% w/w, such that only chemical raw materials and mixtures containing listed PFAS above 1% w/w are within scope.

Scope

Based on clarifications provided by Taiwan MOENV during its June 2026 seminar on the revised draft, the Toxic and Concerned Chemical Substances Control Act (TCCSCA) and the proposed PFAS management requirements regulate chemical substances (chemical raw materials) and bulk mixtures only. Finished articles and equipment are not within the scope of the proposed regulation.

Based on the current draft and MOENV’s published clarifications, no. Since finished articles and equipment are outside the scope of the regulation, importers are not expected under this regulation to determine whether listed PFAS substances are present within finished equipment, components, or supplier assemblies.

Reporting and Record Keeping

No. Based on the current draft and MOENV’s clarification that finished articles are excluded, importers of finished equipment would not be subject to the quarterly reporting or monthly recordkeeping requirements established under the proposed regulation.

Labelling Requirements 

The proposed labeling requirements apply only to the containers and packaging of regulated chemical substances and mixtures. Based on the current draft and MOENV’s clarification that articles are excluded, labeling obligations do not extend to imported articles or equipment containing PFAS materials.

Demonstration of Conformity 

For regulated chemical substances and mixtures, compliance is expected to be demonstrated primarily through Safety Data Sheets (SDSs), import/manufacturing approvals, and other supporting documentation, including supplier information where appropriate. Analytical testing appears to be intended as a supplementary verification tool, rather than the primary means of demonstrating compliance.

Publication of Supporting Documents

Following the stakeholder seminar introducing the revised draft, MOENV released an official Q&A document addressing a number of stakeholder questions. At present, this Q&A document represents the principal implementation guidance available.

Enforcement

At this stage, MOENV has not published enforcement guidance or indicated specific enforcement priorities. Based on the current draft and official clarifications, the regulation is directed toward chemical substances and mixtures, rather than finished articles or complex equipment.

New Mexico Toxic PFAS in Consumer Products NMAC 20.13.2 Rule

Scope 

Regarding the scope of PFAS labeling and reporting requirements for New Mexico (20.13.2 NMAC), the scopes differ slightly for labeling and reporting.

Per 20.13.2.13(B) NMAC, the labeling requirements of this rule do not apply to the following:

  • Used products offered for sale or resale;
  • Products for which labeling requirements are preempted per the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. Section 136v, or for which labeling requirements currently exist at 40 C.F.R. 156.10;
  • Veterinary products and the packaging of veterinary products (as specified); and
  • Medical devices, drugs, and their packaging (as specified). 

Please note that per 20.13.2.13(F), also part of the labeling requirements, the Department of Environment (Department) may waive these labeling requirements for a product or product class if the product is exempt pursuant to 20.13.2.10 NMAC, and none of the product’s material containing intentionally added per- or poly-fluoroalkyl substances will ever come into direct with a consumer while they are using the product as intended during the useful life of the product. However, a request must be submitted to the Department in order for this waiver to be considered. 20.13.2.10 NMAC contains the general exemptions list.

For the reporting requirements in 20.13.2.12 NMAC, products included in the exemption list per 20.13.2.10 NMAC would not be required to comply.

The following is the listing of the exemptions per 20.13.2.10 NMAC:

  • Products for which federal law governs the presence of a per- or poly-fluoroalkyl substance in the product in a way that preempts state authority;
  • Used products offered for sale or resale;
  • Medical devices or drugs and the packaging (as specified), including prosthetic and orthotic devices;
  • Cooling, heating, ventilation, air conditioning or refrigeration equipment that contains intentionally added per- or poly-fluoroalkyl substances or refrigerants listed as acceptable, acceptable subject to use conditions or acceptable to narrowed use limits by the United States Environmental Protection Agency (EPA) pursuant to the significant new alternatives policy program, as specified;
  • Veterinary products and their packaging, as specified;
  • Products developed or manufactured for the purpose of public health or environmental or water quality testing;
  • Motor vehicle or motor vehicle equipment regulated under a federal motor vehicle safety standard, as specified;
  • Any other motor vehicle, including an off-highway vehicle or a specialty motor vehicle, such as an all-terrain vehicle, a side by-side vehicle, farm equipment or a personal assistive mobility device;
  • Watercraft, an aircraft, a lighter-than air aircraft or a seaplane;
  • Semiconductors, including semiconductors incorporated in electronic equipment, and materials used in the manufacture of semiconductors;
  • Non-consumer electronics and non-consumer laboratory equipment not normally used for personal, family or household purposes;
  • Products that contains intentionally added per- or poly-fluoroalkyl substances with uses that are currently listed as acceptable, acceptable per use conditions or acceptable subject to narrowed use limits in the United States EPA’s rules under the significant new alternatives policy program; provided that the product contains per- or poly-fluoroalkyl substances that are being used as substitutes for ozone depleting substances per the conditions specified in the rules;
  • Products used for the generation, distribution or storage of electricity;
  • Equipment directly used in the manufacture or development of the products described in the aforementioned bullet points;
  • Products for which the board has adopted a rule providing that the use of the per- or polyfluoroalkyl substances in that product is a currently unavoidable use (CUU) (see 20.13.2.11 about how to submit a proposal for a CUU);
  • Products that contains fluoropolymers consisting of polymeric substances for which the backbone of the polymer is either a per- or polyfluorinated carbon-only backbone or a perfluorinated polyether backbone that is a solid at standard temperature and pressure;
  • Pesticide that is regulated by or under the jurisdiction of the Federal Insecticide, Fungicide, and Rodenticide Act.

There is not a specific exemption listed in the rule for industrial equipment or processing equipment.

Exemption for Semiconductors 

The exemption for semiconductors and parent products seems to cover only the initial prohibition and reporting deadlines. It does not explicitly exclude these products from PFAS labeling requirements. Thus, if a semiconductor-related product is for consumer use and contains intentionally added PFAS, the PFAS labeling rule might still be applicable starting January 1, 2027, unless the product qualifies for a specific exemption. 

At this time, no separate New Mexico guidance has been identified that establishes specific graphic sizing requirements for the PFAS label; the rule focuses on the required PFAS symbol and clear, legible consumer disclosure rather than providing detailed dimensional specifications. 

Lastly, the Department is set to publish guidelines later this summer regarding the rule.

New Mexico Per- and Polyfluoroalkyl (PFAS) Substances Protection Act  House Bill 212 Enacted

Consumer Products 

The rule applies to manufacturers, distributors, and retailers selling certain PFAS-containing products in the state.

Consumer Products

For the Definition we must go in to the New Mexico PFAS Substances Protection Act, House HB 212 which was enacted in 2025, New Mexico (USA): Per- and Polyfluoroalkyl (PFAS) Substances Protection Act, House Bill 212 Enacted, 2025. The definition is “consumer product” means a tangible personal property that is distributed in commerce and normally used for personal, family or household use, including product categories that are normally used in households but designed for or sold to businesses, such as commercial carpet or floor waxes.

This Regulation can be found in C2P under: New Mexico (USA): Per- and Polyfluoroalkyl (PFAS) Substances Protection Act, House Bill 212 Enacted, 2025

Product Coverage

For the exact product coverage implementation, we go back to the Rule NMAC 20.13.2; section 20.13.2.9, titled “Prohibitions on Products Containing PFAS”.

This section specifically outlines the prohibitions regarding the sale and distribution of products containing intentionally added PFAS. Manufacturers are responsible for identifying these substances in their products as described in subsections A through C of this section. 

  • A. Starting January 1, 2027, certain products such as cookware, food packaging, dental floss, juvenile products, and firefighting foam containing PFAS are banned from sale or distribution in the state.
  • B. From January 1, 2028, the prohibition extends to additional items, including carpets, cleaning products, cosmetics, fabric treatments, feminine hygiene products, textiles, textile furnishings, ski wax, and upholstered furniture.
  • C. By January 1, 2032, products with PFAS can only be sold if a specific rule permitting such use is adopted by the relevant board, or if exempted.
  • D. Beginning January 1, 2028, products demonstrating the presence of PFAS through departmental testing cannot be sold unless the manufacturer provides the requested information.
  • E. After January 1, 2028, sales of any product with added PFAS are forbidden unless the manufacturer has submitted the requisite information to the department. 

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Authors

Catherine Burke

Senior Quality Assurance Lead (Regulatory Content)

Global Regulatory Compliance Professional with Expertise in Toys.

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