Verantwortliche Person under the EU Cosmetics Regulation: what Articles 4 and 5 actually demand

The IKW, the German trade association for body care and detergents, put beauty care sales at 18.012 billion euro for 2025 in market figures dated 3 December 2025, 6.3 per cent up on the year before. Every one of those products carries a name and an address on the pack, and behind that address sits a duty most people outside the sector have never read.

I have recruited in pharma for 16 years, eight at Bayer and five with large CROs, and this is the seat regulatory affairs people ask me about most when they want off the submission treadmill. The verantwortliche Person under the Kosmetikverordnung is regulated far more lightly than anything in pharma, and it gets confused with the safety assessor who signs Part B. The other named statutory functions sit in my overview of statutory roles in German pharma.

Who the statute makes responsible

Article 4(1) is short. "Only cosmetic products for which a legal or natural person is designated within the Community as 'responsible person' shall be placed on the market." Read the first words again. A company can hold the role. That separates it from the sachkundige Person nach § 14 AMG, who must be a named human being with the Sachkenntnis of § 15 AMG.

Article 4(3) makes the EU-established manufacturer the responsible person by default. Where it sits outside the Community, Article 4(4) requires designation, by written mandate, of a person established within the Community who accepts in writing. Article 4(5) makes each importer responsible for the product it places on the market. Article 4(6) catches the distributor who sells under its own name or trademark, or modifies a product so that compliance may be affected. Relabelling a pack can be enough.

Article 19(1)(a) puts the name and address of the responsible person on container and packaging in indelible, easily legible lettering. Whoever appears there is who the authority calls, though the person doing the work usually carries a title like Regulatory Affairs Manager Kosmetik.

What Article 5 puts on the desk

Article 5(1) is a cross-reference list and the closest thing this Regulation has to a job description: compliance with Articles 3, 8, 10 to 18, Article 19(1), (2) and (5), and Articles 20, 21, 23 and 24. Safety, good manufacturing practice, the safety report, the file, notification, restricted substances, the animal testing ban, claims.

Article 5(2) is the part that wakes people at night. A responsible person who considers or has reason to believe that a product it placed on the market is not in conformity shall immediately take the measures necessary to bring it into conformity, withdraw it or recall it, and where there is a risk to human health the authorities must be told at once. Article 25(1) gives them the lever: measures within an expressly stated time limit commensurate with the risk, across eleven listed grounds.

The safety report and the Produktinformationsdatei

Article 10(1) requires the responsible person, before placing a product on the market, to ensure it has undergone a safety assessment and that a safety report is set up in accordance with Annex I. The report has two halves and they are not interchangeable. Part A, the Sicherheitsinformationen, runs to nine headings, from composition and stability through microbiological quality and exposure to the toxicological profile with margins of safety. It is assembled, not judged.

Part B is the judgment, in four items: the conclusion on safety under Article 3, the label warnings under Article 19(1)(d), the reasoning with specific attention to products for children under three and for external intimate hygiene, and the assessor's credentials. Point 4 wants the assessor's name and address, proof of qualification, date and signature. That is where the two roles come apart.

Article 11 makes the paperwork survive. The Produktinformationsdatei is kept ten years after the last batch went on the market. It holds the product description, the safety report, the manufacturing method with a statement on good manufacturing practice compliance, proof of the claimed effect where justified, and any animal testing data. Article 11(3) requires it readily accessible at the address on the label, in a language the authorities easily understand. Plan on German.

The qualification rule that gets misread

Here is the sentence half the sector attributes to the wrong role. Article 10(2): the safety assessment set out in Part B of Annex I "shall be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State."

That requirement attaches to the Sicherheitsbewerter, the safety assessor, not to the verantwortliche Person. A responsible person needs no diploma under the Regulation. It needs to be established in the Union and to make compliance happen. In mid-sized German firms a pharmacist or toxicologist often does both jobs, and an inspector still reads the two bases separately.

Neither role carries a statutory refresher duty. What the market built instead is voluntary. The DGK, the Deutsche Gesellschaft für wissenschaftliche und angewandte Kosmetik, has run safety assessor training with the IKW since 1998, and its DGK-Sicherheitsbewerter certificate takes eight courses plus three seminars in three years, runs five years and is extended by further seminars. The technical reference is the SCCS Notes of Guidance, 12th revision, SCCS/1647/22.

Notification, labelling and public access

Article 13(1) requires electronic submission to the Commission before a product goes on the market: category and name, the responsible person and the address where the file is kept, country of origin for imports, a contact person, nanomaterials with identification and foreseeable exposure, CMR category 1A or 1B substances, and the frame formulation for poison centres. That goes into the CPNP, the Cosmetic Product Notification Portal. It is a notification, not an approval, and nobody vets the file. Article 16(3) adds six months for nanomaterials.

Article 20 restricts claims, backed by Commission Regulation (EU) No 655/2013 and its common criteria. Article 21 is the one people forget. The responsible person shall ensure that the qualitative and quantitative composition, the code number and supplier identity for perfume compositions, and existing data on undesirable and serious undesirable effects are easily accessible to the public by any appropriate means.

How Germany enforces it

The Regulation applies directly, so Germany adds procedure. The Kosmetik-Verordnung of 16 July 2014 supplies it. § 3 KosmetikV imposes an Anzeigepflicht: manufacturers report the place of manufacture before products go on the market, importers the place at which they bring goods into scope, and changes the same way. That notice goes to the Land, not to Berlin.

Enforcement sits with the Länder under the Lebensmittel- und Futtermittelgesetzbuch, the LFGB. Lebensmittelüberwachung inspectors visit sites and take samples, and the Land investigation offices review the documentation. The BVL coordinates nationwide programmes and is national contact point for the CPNP. Article 22 requires in-market controls including file checks, monitoring of good manufacturing practice, and a review of surveillance activities at least every four years.

Article 23(1) is the pharmacovigilance analogue: on serious undesirable effects, the responsible person and distributors shall without delay notify the competent authority, naming the product and any corrective measures. Failure bites through § 8 KosmetikV, which routes offences into § 58(3) and § 59(3) LFGB, where § 58(1) carries up to three years' imprisonment or a fine. § 9 KosmetikV sends lesser breaches to § 60 LFGB, capped at 50 000 euro.

Outsourcing, the UK split, and what a CV must evidence

Article 4(4) makes outsourcing lawful and an industry grew on it. Consultancies and laboratories sell it as a subscription: they take the mandate, hold the file at their German address, run the notification and take the authority's calls. A brand outside the EU wanting German shelf space usually buys the role. Brexit split it in two. Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 rewrote the Regulation for Great Britain, requiring a responsible person established in the United Kingdom, with the SCPN portal and the OPSS. Article 5A treats a Northern Ireland responsible person complying with the EU Regulation as compliant for qualifying Northern Ireland goods. A UK brand selling into Germany still needs an EU-established responsible person.

Employers fall into groups. Brand manufacturers put it in regulatory affairs or quality. Lohnhersteller, the contract manufacturers filling private label for the drugstore chains, hold it for their own output. Importers picking up Asian or American brands hold it because Article 4(5) leaves no choice. Retail own labels run it in-house. Pharma people crossing over bring dossier discipline, GMP audit exposure and adverse event handling, and give up the marketing authorisation as a shield. The reverse move is harder, because pharma has gates such as the one behind the sachkundige Person under § 14 AMG that cosmetics does not.

For a CV, write the German strings literally. Verantwortliche Person nach Artikel 4 der Verordnung (EG) Nr. 1223/2009. Sicherheitsbewerter, if you hold the Article 10(2) qualification, with the degree subject named. Produktinformationsdatei. CPNP-Notifizierung, with the number of SKUs. Anzeigepflicht nach § 3 KosmetikV. Say whether the mandate covered your own employer or clients, and how many. Name the categories, because sunscreen and products for children under three carry a heavier burden. Applicant tracking systems match them literally, which is why I wrote a guide on the ATS in pharma. On pay I print no band, because I have no source I would defend. What moves it is whether you also sign Part B, how many mandates you carry, and whether your record reads as GMP quality or marketing support.

Frequently asked questions

Does the responsible person need a degree in pharmacy or toxicology?

No. Regulation 1223/2009 sets no qualification for the responsible person under Article 4. The diploma requirement in Article 10(2) applies to whoever carries out the safety assessment in Part B of Annex I, who needs a university qualification in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State. One organisation often holds both.

Can a company outside the EU be the responsible person?

No. Article 4(1) requires designation of a person established within the Community. A manufacturer outside it must designate, by written mandate, a person established within the Community who accepts in writing, under Article 4(4). For imports Article 4(5) makes each importer responsible for what it places on the market, and it may pass the role on by mandate.

Is CPNP notification an approval?

No. Article 13 requires the responsible person to submit product information electronically before placing the product on the market, including the frame formulation for poison centre use, and the portal issues no assessment. Article 16(3) sets a separate six-month advance notification for nanomaterials. The compliance decision stays with the responsible person, which is why the role carries liability.

Which authority do I deal with in Germany?

The Land authority. § 3 KosmetikV requires the place of manufacture or import to be notified to the Land, and the Lebensmittelüberwachung of the Länder runs inspections, sampling and file checks under Article 22. The BVL coordinates nationwide programmes and is national contact point for the CPNP.

Sources

Regulation (EC) No 1223/2009, consolidated text, Articles 4, 5, 7, 10, 11, 13, 16, 19, 20, 21, 22, 23 (health.ec.europa.eu, English, PDF)
Regulation (EC) No 1223/2009 on cosmetic products, ELI record (eur-lex.europa.eu, English)
Annex I, Cosmetic Product Safety Report, Part A items 1 to 9 and Part B items 1 to 4 (legislation.gov.uk, English)
Article 10, Safety assessment, including the paragraph 2 qualification wording (legislation.gov.uk, English)
Article 25, Non-compliance by the responsible person, grounds (a) to (k) (legislation.gov.uk, English)
Commission Regulation (EU) No 655/2013, common criteria for cosmetic claims (eur-lex.europa.eu, English)
SCCS Notes of Guidance, 12th revision, SCCS/1647/22, adopted 15 May 2023 (health.ec.europa.eu, English)
Harmonised standards for cosmetic products, EN ISO 22716:2007 on GMP (single-market-economy.ec.europa.eu, English)
Kosmetik-Verordnung 2014, section index including § 3, § 8 and § 9 (urteile-gesetze.de, German)
§ 3 KosmetikV, Anzeigepflichten for place of manufacture and place of import (urteile-gesetze.de, German)
§ 8 KosmetikV, Straftaten and the routing into §§ 58 and 59 LFGB (urteile-gesetze.de, German)
§ 9 KosmetikV, Ordnungswidrigkeiten and the routing into § 60 LFGB (urteile-gesetze.de, German)
§ 58 LFGB, Strafvorschriften, up to three years' imprisonment or a fine (dejure.org, German)
§ 60 LFGB, Bußgeldvorschriften, fine ceilings of 100 000, 50 000 and 20 000 euro (dejure.org, German)
§ 14 AMG, sachkundige Person nach § 14 with the Sachkenntnis of § 15 AMG (dejure.org, German)
BVL, Kosmetik, national contact point role and Länder surveillance (bvl.bund.de, German)
BVL, FAQ zu kosmetischen Mitteln, CPNP is not an approval procedure (bvl.bund.de, German)
IHK München, Merkblatt Kosmetikrecht 2023, responsible person, PIF, CPNP, German authorities (ihk-muenchen.de, German, PDF)
IT-Recht Kanzlei, Die verantwortliche Person im Kosmetikrecht, Rolle und Haftungsrisiken (it-recht-kanzlei.de, German)
DGK and IKW, Fortbildungen für Sicherheitsbewerter, certificate conditions and validity (sicherheitsbewerter.info, German)
DGK e.V., Weiterbildungen including the Sicherheitsbewerter programme (dgk-ev.de, German)
IKW, Fakten und Zahlen, 465 member companies and 178 000 jobs (ikw.org, German)
IKW Marktzahlen of 3 December 2025, beauty care 18 012 million euro in 2025, plus 6.3 per cent (ikw.org, German, PDF)
Schedule 34, Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, UK responsible person and Article 5A on Northern Ireland (legislation.gov.uk, English)
UK Cosmetics Regulation in practice, UK Responsible Person, SCPN portal and OPSS (biorius.com, English)
Responsible person function offered as a consultancy service in Germany (dr-steisslinger-consulting.com, German)
COSICHEM, Responsible Person service offering (cosichem.de, German)

© 29 July 2026 Andreas Schulz. All rights reserved. This article is career guidance, not legal advice; the statutory text prevails.