Germany Cosmetics Regulation QA
Email: fra4ww@evershinecpa.com
The Engaging Manager from Headquarter
Ms. Anna Wang, Speak German, English, and Chinese.
skype: burlinna
HLF-TW-10
What are the categories of cosmetics in Germany? What is its official name?
What is the intensity of management of different categories?
What is the governmental authority of cosmetics? Website?
Evershine RD：
‘Cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.
Germany is a member state of the European Union, and the import and sale of cosmetics must comply with the cosmetic regulations of the EU agreement. Cosmetics can be sold after completing the electronic registration through the European Union’s cosmetic regulations and after passing the tests for harmful substances and heavy metals required by cosmetics in the German local laws: Lebensmittel- und Futtermittelgesetzbuches (LFGB).
【參考連結】
https://www.bfr.bund.de/de/start.html
https://www.bvl.bund.de/EN/Home/home_node.html
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009R1223-20220301
HLF-TW-20
If a foreign company wants to sell cosmetics in Germany, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration?
If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
No business license is required.
【參考連結】
HLF-TW-25
假如需要辦理，請問德國有專業服務公司可以協助辦理化妝品公司營業許可證？
Evershine RD：
Gurcan Partners https://gurcanpartners.com/en/
Firma https://www.firma.de/en/
HLF-TW-30
If a foreign company wants to sell cosmetics in Germany, can it assign a Germany company to act as a business agent?
What are the requests for acting as a business agent? What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
Yes. Only cosmetic products for which a legal or natural person is designated within the EU as a ‘responsible person’ can be placed on the market. The new cosmetics regulation allows the precise identification of the responsible person is and clearly outlines their obligations. For non-EU goods entering the EU and EFTA regions, according to regulations, a local legal person or natural person in the EU must be designated as the company’s “designated person in charge” Responsible Person (RP) in order to sell products in the EU region. Responsibilities of the person in charge of the product: to ensure the compliance of the products introduced into the European market, to undertake all the relevant obligations stipulated by the EU cosmetics regulations, and to be the main contact person for cooperation with the competent authorities.
The Designated Responsible Person can be:
1. Manufacturer: If manufactured within the EU.
2. Importer: If the product manufacturer manufactures outside the EU.
3. Distributors: if they put their own brand products on the market.
4. Designated person or company: designated by the manufacturer or importer and authorized in writing.
Prerequisites must meet one of the qualifications:
1. EU citizens (regardless of residence).
2. Natural persons resident in the European Union or in a member state of the European Economic Area.
3. A company established in the European Union or the European Economic Area (registered office, central authority or principal body).
4. Organizations established in the EU or the European Economic Area.
Responsible person’s obligations:
1. Ensure that the cosmetic product complies with EU cosmetic regulations
2. Ensure that the cosmetic is harmless to human health and safety. Before the cosmetic is put on the market, ensure that the cosmetic has completed the safety assessment and meets the standards, and must provide sufficient consumer information.
3. When the cosmetics are listed, the person in charge shall keep the product information files for ten years from the date of the last batch of cosmetics.
4. The product information file should be prepared for inspection by the competent authorities of the member states in the place of sale, and it should be provided in a language that the competent authorities of the member states can easily understand.
5. Before selling cosmetics, the person in charge should electronically send the information to the Executive Committee, and the Executive Committee should also promptly transmit the information to the competent authorities of member states.
． Cosmetics category, name
． Name and address of the person in charge of the product
． country of origin
． Member State placing the cosmetic on the market
． Nanomaterials (including chemical name, exposure conditions). Name and Chemical Abstract or EC Number of the carcinogenic, mutagenic or reproductive toxicant
． Medical treatment in case of problems.
6. When cosmetics are sold, the person in charge shall notify the committee of the original label, reasonable and clear packaging photos.
7. In the event of serious doubt as to the safety of any substance contained in cosmetic products, the competent authority of the Member State in which products containing the substance are marketed may, upon reasonable request, require the person in charge to submit a copy of which he is responsible and contains such substance. All cosmetic list of substances. The list should indicate the concentration of the substance in the cosmetic.
8. If the product does not meet the regulations, the responsible person must recall the product that has been sold in the European Union. If the cosmetic product is in compliance with the regulations but it is still proven to be harmful to the human body, the competent authority of each member state may take necessary measures, and may also require the product to be recalled.
【參考連結】
https://www.handelsregister.de/rp_web/welcome.do?language=en&sec_ip=79.114.177.118
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009R1223-20220301
HLF-TW-35
假如需要辦理指派德國公司擔任營業代理人，請問德國有專業服務公司可以協助？
Evershine RD：
BB+ Distribution GmbH https://beautybrands.plus/
FLOWING https://flowing-cosmetics.com/?lang=en/
MATIVA https://mativagroup.com/
HLF-TW-40
Do foreign companies need to apply for an approval before importing cosmetics sold to Germany?
If yes, which authority is in charge? What documents are required? What is the application process?
Do cosmetics packaging and labeling require prior approval? In addition to German, which other languages are allowed? Website?
Evershine RD：
The EU cosmetics regulations stipulate that enterprises, before selling cosmetics products, need to complete the electronic registration in the cosmetics registration system. The European Commission will communicate the login information to the competent authorities and poison management centres or relevant bodies of each Member State.
Required documents:
1. Cosmetics name and category
2. Name and address of the responsible person
3. Country of Origin
4. Member States where the cosmetic product will be marketed
5. If necessary, the actual contact details should be indicated
6. Nanomaterials
7. Presence of CMR Substances
8. Medical treatment in case of problems
9. Photos of the original label and packaging
Before selling in Germany, it is necessary to notify the competent regulatory agencies of the federal states, and after passing the inspection of harmful substances stipulated in Germany, the cosmetics can be sold.
Notification content:
1. Manufacture of cosmetic products, ingredients, materials, intended use
2. Placing on the market
3. Cosmetic evaluation results
4. Information of the responsible person
5. Quantitative or substantive composition of cosmetics
6. Side effects to human health, etc.
Test items:
1. Testing of harmful chemical ingredients and heavy metals in cosmetics.
2. Certain ingredients like preservatives, dyes or UV filters must be approved.
Labeling and Packaging
Without prejudice to other provisions in this Article, cosmetic products shall be made available on the market only where the container and packaging of cosmetic products bear the following information in indelible, easily legible and visible lettering:
1. Responsible person or company name and address
2. Origin Country of Imported Cosmetics
3. Capacities (expressed by weight or volume) as packaged, except for packages less than 5g or 5ml, free samples and single-use packages. For prepackages that are usually sold as multiples, the details of their weight or volume are not important, as long as the number of items appears on the package, the content need not be provided.
4. Minimum shelf life: should be clearly stated and should be composed in the order of month/year or day/month/year. If necessary, this information shall be supplemented by a description of the conditions that must be met in order to guarantee the specified durability. For cosmetic products with a minimum shelf life of more than 30 months, the expiration date should not be mandatory. For such products, the safety period of the product after opening should be stated and it can be used without harming the consumer.
5. Precautions for use: Contains the precautions for professional products listed in the EU Cosmetics Regulations.
6. Manufacturing batch number or basis, if this is not possible because the cosmetic is too small or due to practical reasons, such information is indicated on the packaging.
7. The product functions of cosmetics can only be indicated on the package, and the word “ingredients” must be used before the list.
8. List of ingredients: If the content of the ingredients is ≥1%, they are listed in the order of highest content; if the content is less than 1%, they can be listed in any order. The list of ingredients may only be indicated on the packaging. Ingredient means any substance or mixture that is intentionally used in the manufacture of cosmetic products, the following should not be considered as ingredients:
． Impurities in the raw materials
． Auxiliary technology materials used in mixtures but not present in final products
9. Other Notes
． Perfume, fragrance composition and its raw materials shall be called “perfume” or “aroma”, except for the two terms of essence or fragrance, which need to be indicated in the ingredient list
． All ingredients in the form of nanomaterials should be clearly stated in the ingredient list
． Colorants other than colorants used in hair coloring may be listed after other cosmetic ingredients in any order.For decorative cosmetics sold in multiple shades, all colorants except those used for hair coloring may be listed, provided the word “may contain” or the symbol “+/-” is added. (CI (Color Index) nomenclature should be used)
． For soaps, bath balls, and other small products, for practical reasons, the information cannot appear on the label, hang tag, tape or card or accompanying flyer, this information should appear on the notice immediately adjacent to the cosmetic sales container.
．Germany is one of the 27 member states of the EU, and the Cosmetic Labeling Act requires certain information on the label to be in the official language of the country of sale: German.
【參考連結】
https://ec.europa.eu/growth/sectors/cosmetics/cosmetic-product-notification-portal_en
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009R1223-20220301
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009R1223-20220301
http://www.gesetze-im-internet.de/
HLF-TW-45
請問在德國有哪些專業服務機構，可以協助辦理化妝品產品許可證？
Evershine RD：
MDSS https://mdsscosmetics.com/
MedNet https://www.mednet-ecrep.com/
HLF-TW-50
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge?
What documents are required? What is the application process? Do cosmetics packaging and labeling require prior approval?
In addition to German, which other languages are allowed? Website?
Evershine RD：
Only companies or natural persons registered in the EU member states can apply.
Prerequisites must meet one of the qualifications:
1. EU citizens (regardless of residence).
2. Natural persons resident in the European Union or in a member state of the European Economic Area.
3. A company established in the European Union or the European Economic Area (registered office, central authority or principal body).
4. Organizations established in the EU or the European Economic Area.
The EU cosmetics regulations stipulate that enterprises, before selling cosmetics products, need to complete the electronic registration in the cosmetics registration system.
Required documents:
1. Cosmetics name and category
2. Name and address of the responsible person
3. Country of Origin
4. Member States where the cosmetic product will be marketed
5. If necessary, the actual contact details should be indicated
6. Nanomaterials
7. Presence of CMR Substances
8. Medical treatment in case of problems
9. Photos of the original label and packaging
Labeling and Packaging
Without prejudice to other provisions in this Article, cosmetic products shall be made available on the market only where the container and packaging of cosmetic products bear the following information in indelible, easily legible and visible lettering:
1. Responsible person or company name and address
2. Origin Country of Imported Cosmetics
3. Capacities (expressed by weight or volume) as packaged, except for packages less than 5g or 5ml, free samples and single-use packages. For prepackages that are usually sold as multiples, the details of their weight or volume are not important, as long as the number of items appears on the package, the content need not be provided.
4. Minimum shelf life: should be clearly stated and should be composed in the order of month/year or day/month/year. If necessary, this information shall be supplemented by a description of the conditions that must be met in order to guarantee the specified durability. For cosmetic products with a minimum shelf life of more than 30 months, the expiration date should not be mandatory. For such products, the safety period of the product after opening should be stated and it can be used without harming the consumer.
5. Precautions for use: Contains the precautions for professional products listed in the EU Cosmetics Regulations.
6. Manufacturing batch number or basis, if this is not possible because the cosmetic is too small or due to practical reasons, such information is indicated on the packaging.
7. The product functions of cosmetics can only be indicated on the package, and the word “ingredients” must be used before the list.
8. List of ingredients: If the content of the ingredients is ≥1%, they are listed in the order of highest content; if the content is less than 1%, they can be listed in any order. The list of ingredients may only be indicated on the packaging. Ingredient means any substance or mixture that is intentionally used in the manufacture of cosmetic products, the following should not be considered as ingredients:
． Impurities in the raw materials
． Auxiliary technology materials used in mixtures but not present in final products
9. Other Notes
． Perfume, fragrance composition and its raw materials shall be called “perfume” or “aroma”, except for the two terms of essence or fragrance, which need to be indicated in the ingredient list
． All ingredients in the form of nanomaterials should be clearly stated in the ingredient list
． Colorants other than colorants used in hair coloring may be listed after other cosmetic ingredients in any order.For decorative cosmetics sold in multiple shades, all colorants except those used for hair coloring may be listed, provided the word “may contain” or the symbol “+/-” is added. (CI (Color Index) nomenclature should be used)
． For soaps, bath balls, and other small products, for practical reasons, the information cannot appear on the label, hang tag, tape or card or accompanying flyer, this information should appear on the notice immediately adjacent to the cosmetic sales container.
．Germany is one of the 27 member states of the EU, and the Cosmetic Labeling Act requires certain information on the label to be in the official language of the country of sale: German.
【參考連結】
https://ec.europa.eu/growth/sectors/cosmetics/cosmetic-product-notification-portal_en
HLF-TW-55
請問在德國有哪些專業服務機構，可以協助以外國公司名義辦理化妝品產品許可證？
Evershine RD：
MDSS https://mdsscosmetics.com/
MedNet https://www.mednet-ecrep.com/
HLF-TW-60
What documents are required when importing approved cosmetics into Germany? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
The EU cosmetics regulations stipulate that enterprises, before selling cosmetics products, need to complete the electronic registration in the cosmetics registration system. The European Commission will communicate the login information to the competent authorities and poison management centres or relevant bodies of each Member State.
Required documents:
1. Cosmetics name and category
2. Name and address of the responsible person
3. Country of Origin
4. Member States where the cosmetic product will be marketed
5. If necessary, the actual contact details should be indicated
6. Nanomaterials
7. Presence of CMR Substances
8. Medical treatment in case of problems
9. Photos of the original label and packaging
Before selling in Germany, it is necessary to notify the competent regulatory agencies of the federal states, and after passing the inspection of harmful substances stipulated in Germany, the cosmetics can be sold.
Notification content:
1. Manufacture of cosmetic products, ingredients, materials, intended use
2. Placing on the market
3. Cosmetic evaluation results
4. Information of the responsible person
5. Quantitative or substantive composition of cosmetics
6. Side effects to human health, etc.
Test items:
1. Testing of harmful chemical ingredients and heavy metals in cosmetics.
2. Certain ingredients like preservatives, dyes or UV filters must be approved.
【參考連結】
https://ec.europa.eu/growth/sectors/cosmetics/cosmetic-product-notification-portal_en
https://www.bmj.de/DE/Startseite/Startseite_node.html
https://www.bvl.bund.de/EN/Home/home_node.html
HLF-TW-70
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
The responsible person needs to apply in the EU’s Cosmetic Notification Portal (CPNP), including the following:
1.Compliance with Good Manufacturing Practices (GMP)
Other standards or systems of the same level as this standard may also be used. In the EU region, it is self-managed by the industry, and the company does not need to provide any GMP certificate or require the EU competent authority to issue GMP certification.
2.Product Information File (PIF) for Cosmetic Safety Report (CPSR)
． Qualitative and quantitative composition of product ingredients
． Cosmetics physical, chemical and stability
． Microbial content
． Information on Impurities, Residues and Packaging Materials
． Product Labeling and Warnings
． Use of cosmetics
． Toxicological information on ingredients, ingredients
． Adverse Reactions and Serious Adverse Reactions
． (Other related) information on cosmetics, etc.
3.Animal experiments and verification results
4. Nanomaterials
．If necessary, the Scientific Committee on Consumer Safety (SCCS) will be commissioned to assess the safety of nanomaterials.
【參考連結】
https://ec.europa.eu/growth/sectors/cosmetics/cosmetic-product-notification-portal_en
HLF-TW-75
德國化妝品審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？
Evershine RD：
於歐盟申請時可以提交海外檢驗機構資料，但於德國銷售前申請的毒物檢測需提交至德國機構。
海外化妝品檢驗機構
SGS
德國有毒物質檢測機構 (官網提供)
Giftnotruf Berlin
https://giftnotruf.charite.de/
Giftzentrale Bonn
GGIZ
https://www.ggiz-erfurt.de/home.html
Vergiftungs-Informations-Zentrale Freiburg
GIZ
Universität Mainz
http://www.giftinfo.uni-mainz.de/
Giftnotruf München
https://toxikologie.mri.tum.de/de/giftnotruf-muenchen
【參考連結】
HLF-TW-77
請問在德國有哪些化妝品檢驗機構可以提供化妝品檢驗服務？網頁？
Evershine RD：
化妝品檢驗服務
SGS
TÜV
有毒物質檢測機構 (官網提供)
Giftnotruf Berlin
https://giftnotruf.charite.de/
Giftzentrale Bonn
GGIZ
https://www.ggiz-erfurt.de/home.html
Vergiftungs-Informations-Zentrale Freiburg
【參考連結】
HLF-TW-80
After a foreign subsidiary imports cosmetics and entrusts a distributor in Germany to sell it, does the distributor need a cosmetics business license? What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
1. In the event of a serious adverse effect, the person in charge and the distributor shall immediately notify the competent authority of the Member State in which the serious adverse effect occurs:
． All serious adverse effects reasonably expected
． The name of the relevant cosmetic product
． Corrective Actions
2. If the responsible person reports serious adverse effects to the competent authority of the affected Member State, that competent authority shall immediately transmit the information referred to in paragraph 1 to the competent authorities of other Member States.
3. If the distributor reports serious adverse effects to the competent authority of the Member State affected, that competent authority shall immediately transmit the information referred to in paragraph 1 to the competent authorities and persons in charge of other Member States.
4. If serious adverse effects are reported by end users or health professionals to the competent authority of the Member State in which they are affected, that competent authority shall immediately transmit the information on the cosmetic product to the competent authorities and responsible persons of the other Member States. .
【參考連結】
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20190813
HLF-TW-85
請問在德國有哪些專精於化妝品銷售與消費權益相關法律服務的業者？
Evershine RD：
Obelis
Biorius
Lawyers Germany
https://www.lawyersgermany.com/
Contact Us
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Email: fra4ww@evershinecpa.com
The Engaging Manager from Headquarter
Ms. Anna Wang, Speak German English and Chinese.
skype: burlinna
or
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linkedin address:Dale Chen
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