Product Compliance
filing/registration/consulting/training
Portugal - National requirements for cosmetics
Portugal is one of the member states of the European Union,Before entering the Portuguese market,You should check if your product meets national requirements.besides,We suggest that you consult local importers and distributors,Understand if there are any additional regulatory requirements.
● Applicable laws and regulatory authorities
In Portugal,The regulation on cosmetics regulation is No189/2008Regulation No. and EU Cosmetic Regulations1223/2009 EC .
The competent department responsible for cosmetics is a government agency under the Ministry of HealthInfarmed.Except for cosmetics,InfarmedAlso responsible for medical devices and drugs.
● Responsible person and qualified technical personnel
According to EU cosmetics regulations,Only designated responsible persons within the EU RP Only products can be launched into the market.EU manufacturers are their ownRP; For companies located outside the European Union,RPIt's the importer.In both cases,It is possible to appoint another entity as the person in charge through written authorization.
in addition,Section189/2008Decree No24Regulations,There must be a qualified technician Responsible technician Assist the responsible person in placing cosmetics in the Portuguese market Regardless of the manufacturer The importer is still designated asRPOther entities of .Qualified technical personnel andRPResponsible for the compliance of cosmetics together.
Qualified technical personnel must have one of the following educational qualifications
1) Pharmacy obtained from EU universities Chemistry biology Diploma in Medicine or Chemical Engineering;
2) A degree in cosmetic chemistry or medicine from a foreign university;
3) Recognized by the Ministry of Education as a degree equivalent to the aforementioned courses.
● Importing cosmetics to Portugal
Importing cosmetics to Portugal for the first time,InfarmedCompliance declaration must be issued Documento de Conformidade .This statement confirms that the product complies with EU cosmetics regulations and has been obtained CPNP.This is necessary for customs clearance.To obtain a declaration of conformity,Importers must use specific forms provided on their website to Infarmed Submit request,The table includes the following content
Importers and technical personnel Responsible technician Name and contact information of;
The name of cosmetics Batch number Country of origin and CPNP number.
Except for the table,Importers must also provideInfarmedProvide the following documents
1 RPcertificate of authorization,If the importer is not the responsible person;
2)By importer and artisan Responsible technician Declaration signed,The importer declares that he has received assistance from qualified technical personnel,Technical personnel statement,Regardless of the contact with the importer,He bears joint and several liability for complying with regulatory requirements;
1) artisan Responsible technician Resume of Safety Assessor;
2) Officially recognized testing laboratory;
3) Issued by third-party organizationsGMPcertificate;
4) Qualitative and quantitative components of cosmetics,Including each componentINCIname CASNumber and Function;
5) Date indicated Signed and approved cosmetic analysis certificate.
6) For subsequent imports of the same cosmetics,Importers only need to submit forms and declarations,Confirm that the product has not been modified,Importer to keep all the above documents.
The company responsible for selling cosmetics in the Portuguese market must provideInfarmedPay marketing fees,The cost is calculated based on the quantity of cosmetics sold.
● Label requirements
Cosmetic labels in Portugal must comply with EU Cosmetic Regulations Section19Requirements for items.besides,Some projects must be in Portuguese Net content Precautions for use Date of product functionality and minimum durability Unless using symbols .