Executive Summary The EU Packaging and Packaging Waste Regulation (EU) 2025/40 (PPWR) has applied in full since 12 August 2026. All four categories of export packaging — food, pharmaceutical, medical device and tobacco — fall within its scope, but each is primarily governed by a different piece of legislation, and each has a different set of exemptions. Only food packaging is governed by Regulation (EC) 1935/2004, which requires compliance with migration limits, positive lists and an assessment of non-intentionally added substances (NIAS). The limits under Regulation (EU) 10/2011 do not apply to the other three categories: pharmaceutical, medical device and tobacco packaging each follow their own product legislation under the pharmaceutical directives, the MDR and IVDR, and the Tobacco Products Directive respectively. There is therefore no single “FCM declaration of conformity” that covers every packaging type. Each category must first establish its primary regulatory basis, and only then layer the PPWR obligations on top. | |
Key points | What it means for exporters |
PPWR legal status | Regulation (EU) 2025/40 entered into force on 11 February 2025 and has applied from 12 August 2026. |
Primary basis differs by category | Food packaging follows (EC) 1935/2004; the other three follow sector-specific product legislation. |
Heavy metals | Combined lead, cadmium, mercury and hexavalent chromium must not exceed 100 mg/kg — no exemption applies to any of the four categories. |
Declaration of conformity | Template per Annex VIII; retain for 5 years (single-use) or 10 years (reusable packaging). |
EPR registration | Must be completed country by country; there is still no single EU-wide registration portal. |
Void space | From January 2030, void space in grouped, transport and e-commerce packaging must not exceed 50%. |
1. Compliance Requirements Across the Four Packaging Categories
The four categories share a common regulator but not a common rulebook. Food packaging is the only category within the scope of Regulation (EC) 1935/2004, and it must therefore satisfy migration limits, positive-list requirements and a NIAS assessment. Pharmaceutical, medical device and tobacco packaging sit outside that regime and are instead driven by product-specific legislation.
The practical consequence is that compliance work cannot be duplicated across categories. A declaration of conformity prepared for a food contact material does not transfer to a pharmaceutical carton or a medical device sterile barrier system. Each packaging type requires its own regulatory mapping, its own test programme and its own documentation set.
It is also worth noting that the PPWR does not replace existing product safety rules. Where the PPWR and sector legislation overlap, both apply, and the more specific product requirement continues to govern the safety and hygiene aspects of the packaging.
2. Compliance Comparison Table
The table below maps the four packaging categories against their primary regulatory basis, core compliance criteria, PPWR exemptions, main testing routes and the key near-term variable for each. It is intended as a starting point for a category-specific gap analysis rather than a substitute for legal advice.
Table 2. Compliance comparison across the four packaging categories.
Dimension | Food packaging | Pharmaceutical packaging | Medical device packaging | Tobacco packaging |
Primary regulatory basis | (EC) 1935/2004; (EU) 10/2011; (EU) 2022/1616; (EC) 2023/2006 | 2001/83/EC; (EU) 2019/6; EU GMP ((EU) 2017/1572; veterinary (EU) 2025/2091); European Pharmacopoeia Chapter 3 monographs (3.1 / 3.2) | MDR (EU) 2017/745; IVDR (EU) 2017/746; harmonised standards EN ISO 11607-1/-2:2020 + A1:2023; EN ISO 10993-1:2025 | TPD 2014/40/EU (Articles 7, 9, 13); SUPD (EU) 2019/904 (Articles 7, 8, Annex Part D); (EU) 2020/2151 |
Core compliance criteria | Specific and overall migration limits; NIAS assessment; sensory testing | Compliance with European Pharmacopoeia monographs; GMP; container closure system under CTD Module 3.2.P.7; anti-tampering features for outer packaging (2011/62/EU) | Sterile barrier integrity; biological compatibility. For devices that are invasive or that administer or deliver fluids, materials containing CMR 1A/1B substances or specified endocrine disruptors above 0.1% w/w require justification (Annex I, 10.4.1) | Health warnings covering 65% of each outer surface (Article 9); components such as filters and rolling paper must not contain flavourings, tobacco or nicotine (Article 7(7)); environmental claims on labelling prohibited (Article 13(1)(e)); SUPD plastic marking |
PPWR exemptions | None | Articles 6(11) and 7(4): primary packaging and outer packaging protecting medicinal product quality are exempt from recyclability and recycled-content requirements. Article 12(11): labelling exemption where there is no label space or where it could affect medicinal safety | Articles 6(11) and 7(4): contact-sensitive packaging exempt (7(4)(b) also covers investigational and trial devices). Article 12(11): labelling exemption where there is no label space or where it could affect safe use. Article 15(11): custom transport packaging for configurable devices exempt from conformity assessment and DoC | None. Article 2(2): the PPWR does not affect specific product safety and hygiene requirements; SUPD marking must not obscure health warnings |
Main testing and verification | Four heavy metals; PFAS (total fluorine plus targeted analysis); migration testing; NIAS screening; bisphenol residues | Four heavy metals; material identification; extractables and leachables studies | Four heavy metals; EN ISO 11607 packaging validation; EN ISO 10993-1 biological evaluation; CMR / ED screening | Four heavy metals; artwork and marking position verification; flavouring and nicotine residues in components |
Key near-term variable | PFAS limits already apply as of August 2026; recycled content targets of 10%–30% by 2030 | Exemptions subject to review in 2035; a recyclability baseline should be established early | Exemptions subject to review in 2035; changing materials can invalidate existing CMR / ED conclusions | TPD and the Tobacco Advertising Directive are being revised together; proposals expected in Q4 2026, with packaging and labelling as a focus |
3. Obligations Common to All Four Packaging Categories
Four obligations apply horizontally across every category, and none of them can be deferred on the basis of the packaging type.
Heavy metals. The combined concentration of lead, cadmium, mercury and hexavalent chromium must not exceed 100 mg/kg. No exemption applies to any of the four categories.
Technical documentation. Technical documentation must be compiled for each packaging type, with contents following PPWR Annex VII.
Packaging declaration of conformity. The template follows Annex VIII. It must be retained for 5 years for single-use packaging and 10 years for reusable packaging. It is not interchangeable with a product DoC or an FCM DoC.
EPR registration. Extended producer responsibility registration must be completed country by country. There is still no unified EU-level registration entry point.
Two further points deserve attention because they are frequently misunderstood. First, the appointment of an authorised representative is not mandatory: a manufacturer may appoint one in writing under Article 17, to retain the DoC and technical documentation on its behalf and to cooperate with market surveillance.
Whether an EPR registration may likewise be delegated is left to each Member State under Article 44(3). Second, the void space requirement applies from January 2030: operators filling grouped, transport or e-commerce packaging must ensure that void space does not exceed 50% (Article 24).
4. Compliance Timeline
The timeline below sets out the milestones that matter most for export planning. Note that the first three dates have already passed as of publication, while the remaining requirements still leave a preparation window.
Table 3. Compliance timeline
Date | Milestone | Categories affected |
2026-07-20 | Bisphenol A ban under (EU) 2024/3190: placing on the market ceases; certain categories extended to 2028-01-20 | Food packaging |
2026-08-12 | PPWR applies in full: substance limits, DoC, technical documentation, EPR | All four |
2026-09-16 | Plastics amendment (EU) 2025/351 applies in full | Food packaging (plastics) |
2028-08-12 | Harmonised recycling marking (earliest application date) | All four |
2030-01-01 | Recyclability must reach at least grade C; recycled content targets; 50% void space limit | All four; partial exemptions for pharmaceutical and medical device packaging |
2035 | Commission review of the exemptions for pharmaceuticals and medical devices | Pharmaceutical and medical device packaging |
5. How CIRS Testing Supports Compliance
Hangzhou CIRS Testing is a laboratory within the CIRS Group, holding both CMA and CNAS accreditation. Its services cover the full chain from testing through to compliance implementation:
Applicability assessment and role allocation between manufacturer, importer and producer
Testing for the four heavy metals, PFAS, FCM migration, NIAS screening and bisphenol residues
Composition analysis and material identification of packaging materials
Recyclability and reusability assessment and grading
Preparation of technical documentation, and drafting and review of PPWR DoC and FCM DoC
EPR registration and filing in individual EU Member States
Acting as the EU authorised representative for PPWR through the CIRS Group’s European entity
Category-specific regulatory compliance review for food, tobacco, pharmaceutical and medical device packaging
About CIRS Testing
Hangzhou CIRS Testing Co., Ltd. is an internationally recognised third-party testing institution and a wholly owned subsidiary of the CIRS Group dedicated to inspection and testing. It is a national high-tech enterprise whose mission is to help companies achieve product compliance and improve the quality of healthy living.
CIRS Testing holds both CMA accreditation and CNAS accreditation from the China National Accreditation Service for Conformity Assessment, with laboratory space exceeding 10,000 square metres. The laboratory is equipped with instruments including GC-MS, GC, HPLC, LC-MS-MS, IC, IR, EDX, AAS, AFS, ICP, ICP-MS, XRD, a multiprobe skin testing system (MPA580), a facial image analyser (VISIA) and a UV solar simulator (SPF).
CIRS Testing operates laboratories covering light industrial consumer goods, the environment, daily chemicals, food contact materials, medical devices, microbiology (P2 level), biocompatibility (animal testing) and efficacy evaluation. The laboratory continuously improves its methods, contributes to national and association standards, and holds a number of laboratory technology patents.
Contact Us
CIRS TESTING | A member of CIRS Group | CMA & CNAS dual-accredited laboratory Email: test@cirs-group.com | Hotline: +86 571-87206587 | Website: www.cirs-testing.com |
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Note: This article is for informational purposes only and does not constitute legal advice.