🍎 Formaldehyde in an aqueous extract of paper and board intended to come into contact with foodstuffs — cold water extract (EN 645) or hot water extract (EN 647), limit of determination 1 mg/kg (0,001 mg/dm² at a grammage of 100 g/m²), spectrophotometric method in accreditation scopes; PN-EN 1541

Food chemistry PN-EN 1541

Overview

WHAT THE STANDARD COVERS. Scope description of EN 1541:2001 in the iTeh catalogue (read on 06.11.2026), in full: “This European Standard specifies the determination of formaldehyde in aqueous extracts prepared from paper and board intended to come into contact with foodstuffs. The limit of determination is 1 mg/kg. This means that for a paper with a grammage of 100 g/m² the limit of determination will be 0,001 mg/dm². For contact at room temperature the cold water extract is applied. For paper and board materials intended for boiling and hot filtering purposes the hot water extract is applied.” In other words: determination of formaldehyde in aqueous extracts of paper and board intended for food contact; limit of determination 1 mg/kg, and for a paper with a grammage of 100 g/m² — 0,001 mg/dm²; for contact at room temperature — the cold water extract, for paper and board intended for boiling and hot filtering — the hot water extract. The catalogue states that the standard refers to EN 645:1993 (preparation of a cold water extract) and EN 647:1993 (preparation of a hot water extract), and is itself referred to by EN 71-9:2005+A1:2007 (safety of toys — organic chemical compounds, requirements). The “Scope” field of the PKN card of PN-EN 1541:2003 (Polish version), in full (in our translation): “A method is given for determining formaldehyde in aqueous extracts prepared from paper and board intended for direct contact with food. The principle of the method, reagents, apparatus, preparation of the test sample, the determination, calculation and expression of results, confirmation of the results of the determination, repeatability and reproducibility of the method and the test report are discussed” — the card therefore lists the parts of the standard but does not give their content.

THE REGULATION THAT CITES THE STANDARD (Commission Directive (EU) 2019/1929 of 19 November 2019, OJ L 299 of 20.11.2019, p. 51 — Polish text). The directive adds formaldehyde to Appendix C of Annex II to Directive 2009/48/EC on the safety of toys; Appendix C concerns toys intended for children under 36 months and other toys intended to be placed in the mouth (recital 1). Recital 8: the limit content of formaldehyde in paper toy material is to be 30 mg/kg, “if determined in accordance with the water extraction method specified in EN 645:1993 and in accordance with EN 1541:2001”. Entry in Appendix C (Art. 1): formaldehyde, CAS 50-00-0 — 1,5 mg/l (migration limit) in polymeric toy materials, 0,1 ml/m³ (emission limit) in resin-bonded wood toy materials, 30 mg/kg each (content limit) in textile, leather and paper toy materials, and 10 mg/kg in water-based toy materials. Member States apply the provisions from 21 May 2021 (Art. 2). For paper the directive specifies the cold water extract (EN 645), not the hot one.

EDITION. EN 1541:2001 (April 2001, approved by CEN on 19 February 2001) superseded EN 1541:1998 (EN title page in the SIST EN 1541:2002 sample). In the iTeh catalogue (read on 06.11.2026) EN 1541:2001 has the status “Published”, committee CEN/TC 172 (working group WG 3 — analytical methods for the assessment of paper and board in contact with foodstuffs), ICS 67.250 and 85.060, and stage “9093 – Decision to confirm – Review Enquiry” (start 13.06.2022) — a decision to confirm the standard after review.

STATUS (state of the PKN card on 06.11.2026). The card of PN-EN 1541:2003 (Polish version) has no withdrawal label: published 20-11-2003, 11 pages, price group F, Consumer Products Sector, KT 25 Pulp, Paper, Board and their Products, “Adopts: EN 1541:2001 [IDT]”, “Supersedes: PN-EN 1541:2002 - English version”, ICS 67.250, 85.060. PKN search, query “EN 1541” (06.11.2026): alongside are the withdrawn PN-EN 1541:2002 (English version, adopted EN 1541:2001; superseded by the 2003 edition) and PN-EN 1541:2000 (Polish version, adopted EN 1541:1998 with corrigendum AC:1998; superseded by the 2002 edition). The 2003 edition is therefore the Polish text of the same EN 1541:2001 that the 2002 version adopted in English. Extraction standards in the PKN search (06.11.2026; cards not opened): PN-EN 645:1998 “Paper and board intended to come into contact with foodstuffs — Preparation of a cold water extract” (Polish version, adopts EN 645:1993) — no withdrawal note; PN-EN 647:1998 “Paper and board intended to come into contact with foodstuffs — Preparation of a hot water extract” (Polish version, adopts EN 647:1993) — no withdrawal note. We did not check the status of PN-EN 71-9.

HOW MANY LABORATORIES AND IN WHAT FORM (copy of the accreditation scope database of 02.11.2026 and current PCA documents downloaded on 06.11.2026). The number EN 1541 (with no digits before or after — EN ISO 11541 and CEN/TS 15414 excluded) appears in 8 records at 8 Polish laboratories, one each: AB 065, AB 079, AB 377, AB 451, AB 486, AB 521, AB 538, AB 910. In the current PCA documents of these 8 laboratories the standard appears in one item each — the same as in the copy. Forms: “PN-EN 1541:2003” (AB 079, AB 377, AB 486, AB 521, AB 538; AB 451 together with PN-EN 645:1998 and PN-EN 647:1998), “PN-EN 1541:2003” together with “EN 1541:2001” (AB 065) and “PN-EN 1541” without a year (AB 910 — together with PN-EN 71-9, PN-EN 645, PN-EN 647 and Directive 2009/48/EC, in a flexible accreditation scope). Among Czech laboratories the number is held by two: 1004 (“ČSN EN 1541”, aqueous extracts of paper and board, photometric method) and 1018.3 (in-house procedure citing ČSN EN 645 and ČSN EN 1541, spectrophotometric method). The “Laboratories” tab (“PN-EN 1541”) shows 10 laboratories: these 8 Polish and 2 Czech (tab query reproduced on the database copy on 06.11.2026).

WHAT THE LABORATORIES TEST (database copy and PCA documents, complete items). All 8 Polish laboratories — spectrophotometric method. Paper and board intended for contact with food — formaldehyde content in an aqueous extract: AB 377 — 0,91–25,0 mg/kg and 0,00091–1,5 mg/dm², AB 521 — 1–20 mg/kg and 0,001–0,02 mg/dm², AB 538 — 1–25 mg/kg; AB 451 — 1,06–26,75 mg/kg (with PN-EN 645 and PN-EN 647). Materials and articles of paper and board and their aqueous extracts — 1,0–30 mg/kg and 0,0010–3,0 mg/dm² (AB 079). Aqueous extract of paper and board — 1–25 mg/kg and 0,001–0,025 mg/dm² (AB 486). Paper, board, pulps — formaldehyde content in an aqueous extract, 1–100 mg/kg (AB 065). Toys and articles of paper and board intended for contact with food — formaldehyde content, no range given (AB 910, with PN-EN 71-9 and Directive 2009/48/EC).

WHERE A SEEMINGLY CORRECT RESULT IS EASY TO GET. First — the type of extract: the standard determines formaldehyde in an extract, and the extract is prepared according to another standard — cold (EN 645) or hot (EN 647), depending on the intended use of the paper; a result from a hot water extract does not answer the question about contact at room temperature and vice versa, and the toy directive specifies the cold water extract. The report should therefore name the extraction standard — in the scopes only AB 451 and AB 910 cite it explicitly. Second — the unit: mg/kg refers to the mass of paper, mg/dm² to its area; they are converted via the grammage (1 mg/kg at 100 g/m² = 0,001 mg/dm²), so a result in mg/dm² compared with a value in mg/kg (e.g. 30 mg/kg from the directive) without the grammage is not comparable. Third — the lower limit: the scope description of the standard gives a limit of determination of 1 mg/kg, while AB 377 declares a range from 0,91 mg/kg — values below 1 mg/kg lie below the limit given in the scope description of the standard; how the laboratory justifies this does not follow from the accreditation scope. Fourth — a different subject: AB 910 also applies the standard in an item on toys, together with PN-EN 71-9; the scope description of EN 1541 speaks only of paper and board for contact with food.

WHAT WE DO NOT GIVE. We did not have the text of the standard: the SIST EN 1541:2002 sample at iTeh contains only title pages, and the pages with content are blacked out. We therefore do not give the reaction principle, reagents, wavelength, calibration, number of extracts and parallel determinations, confirmation of the result, precision data or report requirements; we do not know the content of EN 645 and EN 647 either (sample mass, water volume, extraction time and temperature). We did not check the Polish act transposing Directive 2009/48/EC, its consolidated text or other regulations on food contact materials that might cite the standard.

Method principle

Formaldehyde is determined in an aqueous extract of paper or board prepared cold (EN 645 — contact at room temperature) or hot (EN 647 — paper for boiling and hot filtering); the result is given in mg/kg of paper, and the limit of determination according to the scope description of the standard is 1 mg/kg, i.e. 0,001 mg/dm² at a grammage of 100 g/m². In accreditation scopes all 8 Polish laboratories use a spectrophotometric method; we DO NOT GIVE the course of the determination — we did not have the text of the standard.

Applications

• Paper and board intended to come into contact with foodstuffs — formaldehyde in a cold or hot aqueous extract (scope description of EN 1541:2001)
• Paper toy materials — formaldehyde content limit 30 mg/kg, determined after extraction according to EN 645:1993 and according to EN 1541:2001 (Directive (EU) 2019/1929)
• In accreditation scopes: paper and board for contact with food, articles of paper and board and their aqueous extracts, pulps, toys
• In accreditation scopes: 8 Polish laboratories — from 0,91 to 100 mg/kg and from 0,00091 to 3,0 mg/dm², spectrophotometric method

Key parameters

Standard

Standard number

PN-EN 1541:2003 (Polish version; adopts EN 1541:2001 [IDT])

Title (PL)

Papier i tektura przeznaczone do kontaktu z żywnością — Oznaczanie zawartości formaldehydu w wyciągu wodnym

Title (EN)

Paper and board intended to come into contact with foodstuffs — Determination of formaldehyde in an aqueous extract

Step-by-step procedure

1. Choice of extract

   Contact with food at room temperature — cold water extract (EN 645); paper and board for boiling and hot filtering — hot water extract (EN 647) (scope description of EN 1541:2001). Paper toy material — extract according to EN 645:1993 (Directive (EU) 2019/1929).

2. Determination of formaldehyde in the extract

   In accreditation scopes — spectrophotometric method; we DO NOT GIVE the course — we did not have the text of the standard.

3. Result

   In mg/kg of paper, in scopes also in mg/dm²; conversion via the grammage (1 mg/kg at 100 g/m² = 0,001 mg/dm²). PN-EN 1541:2003 — current (state of the PKN card on 06.11.2026; Polish version).

Required equipment and apparatus

Health and safety (OHS)

• Formaldehyde — carcinogen category 1B (recital 2 of Directive (EU) 2019/1929); work with standards in a fume hood, safety rules of a chemical laboratory
• SUBSTANTIVE NOTE: a result in mg/dm² is not comparable with a value in mg/kg without the grammage of the paper
• SUBSTANTIVE NOTE: the type of extract (cold — EN 645, hot — EN 647) is part of the result

Frequently asked questions