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Forskrift om god distributionspraksis for kosmetiske produkter. Den fastlægger principper og standarder for god distributionspraksis for kosmetiske produkter.

Notifikationsnummer:

2025/0748/PT (Portugal)

Modtagelsesdato:

12/12/2025

Afslutning af status quo-periode:

16/03/2026 (15/06/2026)

Fremsættelse af bemærkninger fra:

European Commission

Afgivelse af en udførlig udtalelse fra:

European Commission

Spain

Forslagstekst:

PT BG HR CS DA NL EN ET FI FR GA DE EL HU IT LV LT MT PL RO SK SL ES SV

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Meddelelse 001

Kommissionens meddelelse - TRIS/(2025) 3599

Direktiv (EU) 2015/1535

Notifikation: 2025/0748/PT

Notifikation af et udkast fra en medlemsstat

Notification – Notification – Notifzierung – Нотификация – Oznámení – Notifikation – Γνωστοποίηση – Notificación – Teavitamine – Ilmoitus – Obavijest – Bejelentés – Notifica – Pranešimas – Paziņojums – Notifika – Kennisgeving – Zawiadomienie – Notificação – Notificare – Oznámenie – Obvestilo – Anmälan – Fógra a thabhairt

Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna

MSG: 20253599.DA

1. MSG 001 IND 2025 0748 PT DA 12-12-2025 PT NOTIF

2. Portugal

3A. Ministério da Economia e da Coesão Territorial
Instituto Português da Qualidade, I.P.
Rua António Gião, n.º 2
2829-513 Caparica
Telefone: + 351 21 294 81 00
Correio eletrónico: not1535@ipq.pt
site: www.ipq.pt

3B. Ministério da Saúde Autoridade Nacional do Medicamento e Produtos de Saúde I.P.,
Parque da Saúde de Lisboa – Av. do Brasil, 53, 1749-004 Lisboa
Telefone: +351 217 987 100
Fax: +351 217 987 316
e-mail: gjc@infarmed.pt site www.infarmed.pt

4. 2025/0748/PT - C20P - Kosmetik

5. Forskrift om god distributionspraksis for kosmetiske produkter. Den fastlægger principper og standarder for god distributionspraksis for kosmetiske produkter.

6. Kosmetiske produkter

7.

8. Den foreslåede forskrift fastlægger principper og standarder for god distributionspraksis for kosmetiske produkter.

Bestemmelserne i dette forslag finder anvendelse på virksomheder, der distribuerer kosmetiske produkter i Portugal eller til Portugal fra en anden medlemsstat, med de nødvendige tilpasninger.

9. Med offentliggørelsen af lovdekret nr. 23/2025 af 19. marts 2025 blev gennemførelsen i national ret af Europa-Parlamentets og Rådets forordning (EF) nr. 1223/2009 af 30. november 2009 (i det følgende benævnt forordning (EF) nr. 1223/2009) om de regler, som kosmetiske produkter, der er tilgængelige på markedet, skal overholde for at sikre et velfungerende indre marked og et højt niveau for beskyttelse af menneskers sundhed.

Dette lovdekret fastsætter også forpligtelsen til registrering af aktivitet for erhvervsdrivende, der fremstiller, importerer eller foretager det første salg i forbindelse med distribution af kosmetiske produkter i Portugal, og indeholder også bestemmelser om etablering og drift af erhvervsdrivende, der opererer i sektoren for kosmetiske produkter.

I betragtning af, at distributionsfasen er afgørende inden for det integrerede leveringssystem for kosmetiske produkter, og under hensyntagen til behovet for at sikre disse produkters kvalitet og sikkerhed i hele markedsføringskæden på det nationale marked, er det derfor vigtigt at gennemføre god distributionspraksis for kosmetiske produkter, som skal overholdes af distributører, der opererer inden for engroshandel, samt af detailhandlere.

10. Henvisninger i grundteksterne:

11. Nej

12.

13. Nej

14. Nej

15. Nej

16.
TBT-aspekt: Nej

SPS-aspekt: Nej

**********
Europa-Kommissionen
Kontaktadresse Direktiv (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu

Disclosed messages

message-id	år	Nummer	Land	Type	Title	Modtagelsesdato
114145	2025	3600	COMEuropa-Kommissionen	003	Receipt of the draft text	12-12-2025
114146	2025	3601	COMEuropa-Kommissionen	037	Competitiveness analysis	12-12-2025
115202	2026	0810	COMEuropa-Kommissionen	315	Classical Detailed Opinion + Comments	13-03-2026
115326	2026	0934	ESSpain	115	Classical Detailed Opinion	26-03-2026

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The Spanish Cosmetics, Toiletry and Perfumery Association(Stanpa) represents the Spanish cosmetics and personal care industry, a highly export-oriented sector and a key contributor to industrial activity, innovation and consumer well-being. The Portuguese market is of particular relevance for our members: in 2025, Portugal was the first destination for Spanish cosmetics and perfumery exports, reaching €982.79 million and +7.65% market growth. Accordingly, any national regulatory requirements liable to affect access conditions in Portugal have a direct and significant impact on intra-EU trade and supply chain operations for Spanish operators (Stanpa) represents the Spanish cosmetics and personal care industry, a highly export-oriented sector and a key contributor to industrial activity, innovation and consumer well-being. The Portuguese market is of particular relevance for our members: in 2025, Portugal was the first destination for Spanish cosmetics and perfumery exports, reaching €982.79 million and +7.65% market growth. Accordingly, any national regulatory requirements liable to affect access conditions in Portugal have a direct and significant impact on intra-EU trade and supply chain operations for Spanish operators.

Stanpa recognizes the EU Cosmetics Products Regulation (Regulation (EC) No 1223/2009, “CPR”) as a robust and comprehensive framework ensuring consumer safety through clear allocation of well-defined responsibilities between the Responsible Person and distributors amongst other operators along the supply chain, supported by market surveillance controls. The Portuguese draft Regulation introduces obligations that diverge from and go beyond the harmonised criteria under the CPR, creating legal uncertainty, duplicative compliance burdens and risks for cross-border distributions.

In the context of TRIS notification 2025/0748/PT, Stanpa reiterates its support for a harmonized and proportionate regulatory framework that ensures a high level of protection of human health while preserving the proper functioning of the Single Market. In this regard, Stanpa fully supports and subscribes to the position submitted by Cosmetics Europe, particularly in light of the importance of the Portuguese market for the Spanish cosmetics and perfumery industry. The Draft Portuguese Regulation introduces additional requirements that risk creating unjustified restrictions to the free movement of goods within the Union. Consequently, the restrictions arising from these new national requirements appear incompatible with EU Internal Market rules.

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The Polish Union of the Cosmetics Industry is the only organization in Poland representing the interests of the cosmetics sector and supporting the strategic development of cosmetics businesses. Together with its more than 270 member companies, the Union has actively contributed to the legislative dialogue shaping the regulatory environment for cosmetic products and to initiatives that foster the development of the Polish cosmetics market, which is currently the fifth largest in the European Union.

The EU Cosmetic Products Regulation (Regulation (EC) No 1223/2009, CPR) has for many years provided a solid regulatory foundation for the European cosmetics industry. It ensures a high level of consumer safety while clearly defining responsibilities along the value chain, in particular those of the Responsible Person and distributors. In addition, the CPR establishes an effective framework for market surveillance and enforcement, which contributes to the proper functioning of the Single Market.

In this context, the Portuguese draft Regulation on Good Distribution Practices for Cosmetic Products appears to introduce requirements that do not fully align with the harmonised EU framework governing cosmetic products. This may create uncertainty regarding the roles and responsibilities of the different economic operators in the supply chain and could ultimately affect the free movement of goods within the Single Market.

At a time of increased geopolitical and economic challenges, legal certainty and the consistent application of harmonised EU rules are essential for maintaining the competitiveness, resilience and innovation capacity of European industries, including the cosmetics sector. The introduction of divergent national requirements in an area already harmonised at EU level risks undermining the coherence of the regulatory framework and the effective functioning of the Single Market. Any national initiative that may affect market access conditions within the European Union should be carefully assessed in light of its potential impact on intra-EU trade, integrated supply chains and the overall competitiveness of European companies operating in the cosmetics sector.

In the context of TRIS notification 2025/0748/PT, The Polish Union of the Cosmetics Industry fully supports and aligns with the position submitted by Cosmetics Europe. We share the concerns raised regarding the potential implications of the proposed Portuguese regulation for the free movement of goods and for the legal clarity of the existing EU framework governing cosmetic products.

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