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EAN/GTIN-number

Please select product type

Enter Product name

Completed by (Name)

Contact information - Mail adress

Date time

Does your article or product package contain substances of very high concern from the Candidate List (SVHCs) in a concentration above 0,1% w/w (REACH article 33)?

Yes

No

If yes: • List the substances • If relevant, attach information to allow safe use of the article • Attach the SCIP number received from the submission of information to the SCIP database of European Chemical Agency (ECHA) • If any substance is listed in annex XIV in REACH, attach the authorization

File upload

Studies/literature reference for the claimed effect

File upload

Type of product including components/materials

Attach safety datasheet (SDS) in Swedish for Swedish market/in Finnish for Finnish market

Is the product a biocidal product?

Yes

No

Registration number for biocidal product at KemI (Sweden only)/Tukes (Finland only)

Attach Certificates/quality system certificate for production

Attach clear Artwork where all the marking is visible (not a product picture on the front only

Studies/literature reference to the claims of effect

Studies/literature upload

Is the product registered in the CPNP-portal?

Yes

No

If no, when are you planning to do so?

Name and address of the responsible person (article 4, EG 1223/2009) or registered place of business within the EU/EEA

Upload INCI-list including function

Marking is according to (EG) nr 1223/2009 and 2013:413 (Sweden)/Kosmetiikkalaki 492/2013 (Finland)

Yes

No

The product fulfills the requirements in (EG) 1223/2009 including requirements on effect and safety report

Yes

No

Is the product marked with open-jar or any other expiry marking; Which?

Table of contents in descending order including source of vitamins and minerals (EG 1170/2009 annex II)

Does the production follow HACCP?

Yes

No

Nutrition or health claims. Reference to EFSA´s application number

Labelled according to EU regulation?

Yes

No

Does the product meet the requirements for EU-organic products (green leaf)? If yes, attach certificate

Yes

No

Attach Certificate here

Choose the option that applies for your product

Meal Replacement

Complete diet replacement for weight control (LCD)

Foods with very low energy content (VLCD)

Responsible manufacturer

Is the manufacturer located outside EU?

Yes

No

Authorized representative within EU according to article 11, (EU) 2017/745 and 2017/746 (only if the manufacturer is located outside EU)

Importer to EU (only if the manufacturer is located outside EU)

Responsible person for the regulation (article 15, EU 2017/745 and 2017/746)

Certified quality system of manufacturer (ISO 13485)

Classification of device

Ingredient declaration upload

Attach Declaration of conformity

Attach certificate by Notified Body (EC-certificate), if applicable

• If relevant, attach information to allow safe use of the article

• Attach the SCIP number received from the submission of information to the SCIP database of European Chemical Agency (ECHA.)

• If any substance is listed in annex XIV in REACH, attach the authorization

Summary over study/literature – Reference for the effect and claim

Does the product fulfill every demand in regulation (EU) 2017/745 or (EU) 2017/746?

Yes

No

Has the product been assigned an UDI by the manufacturer?

Yes

No

Enter product strength

Enter package size

Attach Wholesale dealers licence

Attach GMP-License

Authorization number MT-nr (for Swedish market)/ Myyntilupanumero (for Finnish market)

Components/Materials upload

CE-marked product

Yes

No

Attach the indication and on what standards/requirements

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