Health for humans, animals & plants

Info for companies about cosmetics

Cosmetic products are defined as:

"substances or mixtures intended to come into external contact with the various parts of the human body (skin, hair system, nails, lips, and external intimate regions) or with the teeth and mucous membranes of the oral cavity, for the sole or principal purpose of: cleansing them, perfuming them, changing their appearance, protecting them, keeping them in good condition, or affecting body odor."

Here are links to relevant legislation and cosmetic product guidelines and recommendations. What should be considered when selling cosmetic products? What are the responsibilities of the responsible person and the trade? Important information on the product information file/safety assessment (What should a PID look like and who is allowed to create one?) and contact details.

Kosmetikrecht

Cosmetic products are regulated by the following laws:

  • Regulation Regulation (EC) No. 1223/2009 on cosmetic products applies to all cosmetic products provided in the EU and consists of 40 articles and 71 recitals, the 10 annexes are divided as follows:
Annex I: Safety report (safety information + evaluation)
Annex II: Prohibited substances
Annex III: restricted substances
Annex IV: Dyestuffs
Annex V: Preservatives
Annex VI: UV filters
Annex VII: Symbols
Annex VIII: Alternative methods to animal testing
Annex IX: Part A - Repealed Directive, Part B - List for deadlines for transposition.
Annex X: Correspondence table

Further guidance and guidelines are:

The Austrian Food Codex (Codex for short) summarizes, among other things, what concerns the general perception of trade in Austria. It is an objectified expert opinion. Its purpose is the promulgation of material designations, definitions, examination methods and assessment principles as well as guidelines "for the manufacture and marketing of goods". Chapters relevant to cosmetics manufacturers are:

Organic cosmetics regulation: Directive - Agricultural products from organic production and derived products (RL Biological Production)

International guidelines and ratings

Placing on the market of cosmetics

The European Cosmetics Regulation (EC) No. 1223/2009 stipulates:

"Cosmetic products made available on the market shall be safe for human health under normal or reasonably foreseeable conditions of use, taking into account in particular: Presentation, labeling, instructions for use and disposal, any other indication or information provided by the responsible person. The affixing of warnings does not relieve the responsible person of the obligation to comply with the other requirements of the regulation."

There is no marketing authorization requirement for cosmetic products (first made available on the Community market), i.e., no pre-market regulatory review. However, all requirements and conditions of the cosmetics law (safety report, prohibited substances, etc.) must be fulfilled before placing on the market. The entrepreneur must notify his products on the European database CPNP. Importers who purchase products from third countries are legally equal to manufacturers. The imported products must therefore be manufactured and labeled in accordance with EU law (for details, see Responsible Person and Distributor Responsibilities ).

Responsible person and his tasks

The responsible person is (a legal entity or a natural person):

  • the manufacturer (natural/legal person who manufactures a cosmetic product or natural/legal person who has a cosmetic product manufactured or developed and places it on the market under his own name or trademark) or
  • the importer, or
  • under certain circumstances, the distributor, or
  • a person established within the EU to whom the manufacturer, importer or distributor passes on the responsibility with a written mandate.

According to Art. 4 and 5, the responsible person has to ensure compliance with the Regulation for each cosmetic product placed on the market under his responsibility. Obligations of the responsible person

  • Safety (Art. 3) - Cosmetic products must be safe for human health under normal or reasonably foreseeable use.
  • Notification (Art. 13) - Before being placed on the market, the cosmetic product must be notified electronically to the Commission
  • Manufacture in accordance with Good Manufacturing Practice (Art. 8)
  • Preparation and maintenance of the product information file and the safety assessment (Art. 10 + 11)
  • CMR substances (Art. 15) and prohibited substances (Art. 14 in conjunction with Annex II) may not be used, the substances listed in Annexes III-VI only in accordance with the specified restrictions
  • Nanomaterials (Art.16) - In addition to the notification according to Art. 13, cosmetic products containing nanomaterials must be notified electronically to the Commission six months before they are placed on the market.
  • Labeling (Art.19) and advertising claims (Art.20).
  • notification of serious undesirable effects (Art. 23)
  • Information to the public on qualitative and quantitative composition and on (serious) undesirable effects (Art. 21).

In the following sections, the tasks of the responsible person are described in more detail.

Tasks of the dealers:inside

According to Article 2(1)(e), a "distributor" is any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market.

The distributor is then the responsible person (as defined in Article 4(6)) if he/she: places a cosmetic product on the market under his/her own name and trademark or modifies a product already on the market in such a way that compliance with the applicable requirements may be affected.

The translation of the labeling and information on the cosmetic product already placed on the market is not considered a change in this respect. However, the translation results in the need for notification by the distributor. Before making a product available on the market, the distributor shall verify the labeling, in particular with regard to:

  • name and address, country of origin, batch number, inventory list
  • whether the labeling is in German
  • whether the best-before date has not expired

The trader ensures that the storage or transport conditions meet the requirements of the Ordinance. If a distributor has reason to believe that a cosmetic product does not comply with the requirements of this Ordinance,

  • he/she shall not make the product available on the market
  • he/she shall initiate appropriate corrective action
  • immediately informs the responsible person and the competent authorities if the product poses a risk.

Cosmetic safety assessment

All cosmetic products on the market must be subjected to a safety assessment by qualified experts prior to market launch (preferably already during the development phase). This involves, among other things, a toxicological assessment of the ingredients, taking into account the exposure conditions (application concentration, application duration, application site).

Product information file

The product information file contains the following data in an easily understandable language for the competent authority of the respective member state (usually in German):

The responsible person shall make the product information file readily available to the competent authority at its address indicated on the label, in electronic or other format. The product information file shall be established and kept up to date for each individual cosmetic product made available on the market. It shall be kept for a period of ten years after the date on which the last batch of the cosmetic product was placed on the market.

 

Safety Report

The safety report (Art 10 + Annex I) is the core of the product information file. It must be prepared by the safety assessor in collaboration with the responsible person before the cosmetic product is placed on the market. The safety report consists of two parts:

1) The safety information records all essential characteristics of the cosmetic product and its ingredients that may be relevant to the safety of the product:

  • composition of the product
  • Physical/chemical properties and stability
  • microbiological quality
  • impurities, traces and packaging material
  • normal and reasonably foreseeable use
  • exposure to the product and substances used
  • Toxicological profile of the substances
  • (serious) undesirable effects

2) In the safety assessment, based on the data in the safety report, the safety of the cosmetic product is justified - if necessary, with the addition of certain warnings. Safety assessor

Safety assessments may only be prepared by persons who meet the following requirements (according to Cosmetics Regulation (EC) 1223/2009 Article 10, paragraph 2):

"The cosmetic product safety assessment, as set out in Annex I, Part B, shall be carried out by a person who holds a diploma or other evidence of formal qualification awarded on completion of a theoretical and practical university course in pharmacy, toxicology, medicine, or a similar subject, or a course recognized as equivalent by a Member State."

For a list of cosmetic assessors:in working in Austria and authorized by the Ministry of Health, see the BMSGPK list. Prerequisites and requirements for safety assessors and evaluators are explained on the page of the BMSGPK.

Guidelines and templates

Microbiological requirements

The assurance of microbiological quality is the responsibility of the responsible person, advised by their safety assessor. State of the art for microbiological quality for finished cosmetic products is defined in both ÖNORM EN ISO 17516: 2015 01 01 Cosmetic products - Microbiology - Microbiological limits (ISO 17516:2014) and the 11th revision of the SCCS Notes of Guidance (SCCS/1628/21, Appendix 9).

Quantitative specification

Category 1: cosmetic products intended for use in the eye area, on mucous membranes and on children under three years of age - total live germ count for aerobic mesophilic microorganisms: not more than 10² colony forming units per gram or milliliter (CFU/g or ml). Category 2: Other products - total viable count for aerobic mesophilic microorganisms: not more than 10³ CFU/g or ml.

Qualitative specification

The health safety of cosmetic products may be compromised by a variety of pathogenic agents. The indicator germs described below serve as an orientation for assessment. If there is sufficient suspicion, other pathogens should also be tested on a case-by-case basis. The following specific microorganisms must not be detectable: Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Escherichia coli.

Preservation

Cosmetics Regulation (EC) 1223/2009 stipulates that in the Safety Report Part A (according to Annex I, Z3), results from preservation challenge testing are also used to assess microbiological quality. See also"Challenge testing" in the SCCS Notes of Guidance, 11th revision, Appendix 9. For further information on preservation, see"Shelf life of cosmetics".

Recommendations, publications and guides

On the subject of microbiology and hygiene of cosmetics, experts from the Microbiology and Industrial Hygiene Section of the German Society for Scientific and Applied Cosmetics (DGK e.V.) have provided some publications and books, which you can find here.

The Industrial Association for Personal Care and Detergents e. V. (IKW) has published a very detailed guide for Microbiological Quality Management (MQM) of cosmetic products (IKW 1998).

The following Ö-NORMEN can be obtained here:

  • Cosmetic products - Microbiology - Guidance for risk assessment and identification of low-risk microbiological products (ISO 29621:2010) ÖNORM EN ISO 29621: 2011 03 01
  • Cosmetics - Microbiology - Microbiological limits (ISO 17516:2014) ÖNORM EN ISO 17516: 2015 01 01
  • Cosmetics - Microbiology - General guidance for microbiological testing (ISO 21148:2005) ÖNORM EN ISO 21148: 2009 10 01
  • Cosmetics - Microbiology - Enumeration and detection of aerobic mesophilic bacteria (ISO 21149:2006) ÖNORM EN ISO 21149: 2009 10 01
  • Cosmetic products - Microbiology - Detection of Staphylococcus aureus (ISO/FDIS 22718:2015) ÖNORM EN ISO 22718: 2015 08 01
  • Cosmetic products - Microbiology - Detection of Pseudomonas aeruginosa (ISO/FDIS 22717:2015) ÖNORM EN ISO 22717: 2015 08 01
  • Cosmetic products - Microbiology - Detection of Candida albicans (ISO/FDIS 18416:2015) ÖNORM EN ISO 18416: 2015 08 01
  • Cosmetic products - Microbiology - Detection of Escherichia coli (ISO/FDIS 21150:2015) ÖNORM EN ISO 21150: 2015 08 01
  • Cosmetics - Microbiology - Detection of specified and unspecified microorganisms (ISO 18415:2007, corrected version 2007-12) ÖNORM EN ISO 18415: 2011 07 15
  • Cosmetics - Microbiology - Counting of yeasts and molds (ISO 16212:2008) ÖNORM EN ISO 16212: 2011 07 15
  • Cosmetic products - Microbiology - Evaluation of antimicrobial protection of a cosmetic product (ISO 11930:2012, corrected version 2013-05-01) ÖNORM EN ISO 11930: 2014 03 01

Notify

Each cosmetic product must be notified electronically by the responsible person to the European Commission before being placed on the market (Art. 13).

To carry out the notification, the"Cosmetic Products Notification Portal (CPNP)" has been installed.

The user manual CPNP (Cosmetic Products Notification Portal or Meldeportal für kosmetische Mittel) for responsible person and distributor (German version, last update: 07.03.2018) helps with the registration and entry of your cosmetic products. Further German language instructions for registration and use of the notification portal are offered for download on the homepage of the Federal Ministry of Social Affairs, Health, Care and Consumer Protection (BMSGPK).

If a distributor translates on his own initiative an element of the labeling of a cosmetic product that has already been placed on the market in another Member State, he also has to notify certain data to the European Commission electronically (see Art. 13(3) of Regulation (EC) No 1223/2009).

Good manufacturing practice of cosmetics

Cosmetic GMP (Good Manufacturing Practice) refers to behavioral measures and regulations that must be observed and complied with in the manufacture of cosmetic products, with the aim of reproducibly producing these products in the desired quality.

The legal obligation to apply the principles of "Good Manufacturing Practice" results from Article 8 of the Cosmetics Regulation (EC) No. 1223/2009.

How to implement a Good Manufacturing Practice can be found in the following documents and guidelines:

The following book on microbiology and industrial hygiene can be used as support:

  • DGK Handbook"Industrial Hygiene in Cosmetics" - 2nd revised edition 2019. publishing house for chemical industry, H. Ziolkowsky GmbH, D-86470 Thannhausen/Burg, ISBN 978-3-87846-07-8.

The requirements for a microbiologically and hygienically flawless product are becoming ever more stringent. This book was written from the microbiological or hygienic point of view and is intended to provide practitioners in factories, such as plant managers, developers and those responsible for quality assurance and testing, as well as specialists in other fields, with procedural instructions and practical advice on the implementation of industrial hygiene. All the important aspects of industrial hygiene are brought together here to provide a good overview of the current state of knowledge in the field.

Cosmetic labeling

Mandatory information

The following information must be clearly visible, easily legible and indelible on the packaging AND the container of the cosmetic product according to Article 19, paragraph 1 of Regulation (EU) 1223/2009 (taking into account some exceptions):

The name or company name and address of the responsible person. The information may be abbreviated, provided that this person and his address can be identified from the abbreviation. At the present time, an Internet address alone is not sufficient. The postal address with street, postal code and city name must be given. If more than one address is given, the address of the responsible person where the product information file is made readily available shall be highlighted (e.g. underlined). The country of origin must be indicated if the product is placed on the Community market from a third country. The form in which this information must be provided is not regulated, e.g. "Made in China".

The nominal content at the time of filling, as an indication of weight or volume, with the exception of packages containing less than 5 g or less than 5 ml, free samples and single-use packages; in the case of prepackages which are usually sold as large packages containing several pieces and for which the indication of weight and volume is not important, the indication of the content is not required, provided that the number of pieces is indicated on the package. The indication of the number of pieces is not required if it is easily recognizable from the outside or if the product is usually sold only as a unit.

The date until which the cosmetic product, when properly stored, fulfills its original function and, in particular, is compatible with Article 3 ("Best before date"). The date itself or the reference to the place where it appears on the packaging shall be preceded by the symbol of the hourglass or the words: 'Best before', as indicated in point 3 of Annex VII to Regulation (EC) 1223/2009 .

The date of minimum durability shall be clearly indicated and shall be composed of either the month and the year or the day, the month and the year, in that order. This information shall be supplemented, where necessary, by an indication of the storage conditions which must be fulfilled in order to ensure the indicated shelf life. For cosmetic products with a minimum durability of more than 30 months, the indication of the date of minimum durability is not required. For such products, it is indicated how long the product is safe after opening and can be used without harm to the consumer. For such products, except where the concept of shelf life after opening is not relevant, the length of time the product is safe after opening shall be indicated. This information shall be indicated by the symbol of the opened jar of cream shown in point 2 of Annex VII , followed by the period (expressed in months and/or years).

The special precautions for use, at least the information listed in Annexes III to VI of Regulation (EC) 1223/2009 and any special precautionary statements for cosmetic products intended for professional use.

The batch number or the mark that allows identification of the cosmetic product. If this is not possible for practical reasons due to the small dimensions of the cosmetic products, this information need only appear on the packaging.

The intended use of the cosmetic product, if this is not clear from its presentation.

Ingredients shall be indicated using the common ingredient name according to the glossary published in the Official Journal of the EU: Commission Regulation (EU) 2022/677 of 31 March 2022. If no common ingredient name is available, a name from a generally accepted nomenclature shall be used.

Supportive and clearer is the Commission's database for cosmetic ingredients: CosIng

The ingredients are listed using the International Nomenclature for Cosmetic Ingredients (INCI). However, CosIng does not represent a positive list of cosmetic ingredients, but is merely a collection of ingredients named by the industry.

In addition, 26 perfume ingredients (allergenic fragrances) must be declared due to their allergenic potential above a certain concentration. More on this topic, see Allergenic fragrances

 

Labeling symbols

This symbol (open book with hand) indicates that precautionary measures or the list of ingredients are indicated on a paper strip or card enclosed with or attached to the cosmetic product.

The symbol of the opened cream jar indicates the period of time during which the cosmetic product can still be considered safe after opening the product (shelf life after opening or period after opening - PAO). This period is indicated in months or years in or next to the jar symbol. Months are abbreviated with "M" and years with "J". It must be declared both on the container and on the outer packaging.

The date itself or the reference to the place where the best-before date is indicated on the package is preceded by the hourglass symbol or the wording "Best before..."

Sunscreen products with this symbol (circle with inscription UVA) declare that the cosmetic product in question complies with the EU recommendations on the minimum efficacy of photoprotection against UV-B and UV-A radiation. See "Commission Recommendation 2006/647/EC on the efficacy of sunscreen products and related claims made by the manufacturer.

Allergenic fragrances

According to Cosmetics Regulation (EC) No. 1223/2009 (Article 19 ), 26 ingredients (Annex III) must be additionally declared due to their allergenic potential.

It is not sufficient to declare them under the collective term "perfume" or herbal preparations such as essential oils and extracts if the individual substances are contained in a concentration of more than 0.001% for products that remain on the skin/hair ("leave-on" products) or 0.01% for products that are rinsed off ("rinse-off" products).

Lfd. No. INCI designation other designations CAS No.
45 Benzyl Alcohol 100-51-6
67 Amyl Cinnamal 122-40-7
69 Cinnamyl Alcohol 104-54-1
70 Citral 5392-40-5
71 Eugenol 97-53-0
72 Hydroxycitronellal 107-75-5
73 Isoeugenol 97-54-1
74 Amylcinnamyl alcohol 101-85-9
75 Benzyl Salicylate 118-58-1
76 Cinnamal 104-55-2
77 Coumarin 91-64-5
78 Geraniol 106-24-1
79 Hydroxyisohexyl 3-cyclohexene carboxaldehyde Lyral 31906-04-4*
80 Anise Alcohol Anisyl alcohol 105-13-5
81 Benzyl cinnamate 103-41-3
82 Farnesol 4602-84-0
83 Butylphenyl methylpropional Lilial 80-54-6**
84 Linalool 78-70-6
85 Benzyl benzoate 120-51-4
86 Citronellol 106-22-9
87 Hexyl cinnamal Hexylcinnamaldehyde 101-86-0
88 Limonene d-Limonene 5989-27-5
89 Methyl 2-octynoate Methyl heptine carbonate 111-12-6
90 Alpha-Isomethyl Ionone 127-51-5
91 Evernia Prunastri Extract Oak Moss Extract 90028-68-5
92 Evernia Furfuracea Extract Tree Moss Extract 90028-67-4

*) The fragrance "Hydroxyisohexyl 3-cyclohexene carboxaldehyde" is banned due to its sensitizing properties. As of August 23, 2021, this substance is banned and may no longer be provided. (Regulation (EU) No. 2017/1410)

**) Butylphenyl methylpropional will be banned from March 1, 2022 due to its classification as CMR (reprotoxic) (Regulation (EU) No. 2021/1902).

Advertising claims of cosmetics

Advertising claims must be useful, understandable and reliable and enable end consumers to make an informed purchasing decision.

The requirements for advertising are regulated in Regulation (EC) No 1223/2009 Article 20 "Advertising claims" and Regulation (EU) No 655/2013 establishing common criteria for substantiating advertising claims in relation to cosmetic products.

In the labeling, making available on the market and advertising of cosmetic products, these two regulations prohibit the use of texts, designations, trademarks/brands, illustrations and other pictorial or non-pictorial signs that suggest characteristics or functions that the products in question do not possess.

List of criteria for advertising claims

Regulation (EU) No. 655/2013 includes the following criteria on advertising claims according to the Annex:

  • No advertising that product has been approved or authorized by a public authority.
  • Admissibility of the advertising statement is based on how the average end consumer (reasonably well informed, attentive and critical) perceives this statement, taking into account social, cultural and linguistic factors
  • No advertising that ascribes a specific benefit to a product, but that benefit consists only of compliance with the minimum legal requirements
  • If an ingredient is advertised, it must be specifically present
  • If a property is attributed to an ingredient, the end product must also have the same properties
  • Statements of opinion must not pretend to be verified statements
  • Advertising claims must be supported by sufficient and verifiable evidence
  • Evidence must take into account the state of the art
  • Studies must be relevant to the product and claimed benefit, based on properly developed and applied methods (valid, reliable, and reproducible), and take into account ethical considerations.
  • Weight of evidence must be consistent with the nature of the claims made, especially for claims where lack of efficacy could cause a safety problem.
  • Clearly exaggerated claims do not need to be substantiated.
  • Properties of an ingredient that relate to the final product must be substantiated by sufficient and verifiable evidence: by effective concentration of the ingredient in the product.
  • Acceptability of an advertising claim is based on the weight of the evidence of all available studies, data and information and is determined by the nature of the advertising claim and the general level of knowledge of the end user.
  • Representations about the effects of a product must not go beyond what the available evidence supports.
  • Advertising claims must not attribute any special or unique properties to the product if similar products have the same properties (advertising with self-evidence).
  • If the effect of a product is linked to certain conditions, this must be clearly stated, e.g. use together with other products.
  • No advertising that product has been approved or authorized by a public authority.
  • Admissibility of the advertising statement is based on how the average end consumer (reasonably well informed, attentive and critical) perceives this statement, taking into account social, cultural and linguistic factors
  • No advertising that ascribes a specific benefit to a product, but that benefit consists only of compliance with the minimum legal requirements
  • Advertising claims must be clear and understandable.
  • Advertising statements must contain information to make an informed buying decision.
  • Target audience must be able to grasp the message, i.e. marketing statements must be clear, concise, relevant and understandable to the target audience.

The associated guidance document ("Technical document on cosmetic claims") to Regulation (EU) No. 655/2013 includes:

  • ANNEX I: Common criteria for cosmetic claims with examples and comments.
  • ANNEX II: 'Best practice' for evidence to validate advertising claims.
  • ANNEX III: Free from claims
  • ANNEX IV: Hypoallergenic claim

Disease-related statements

If a cosmetic product advertises claims that the product is intended to cure or alleviate or prevent human disease or pathological conditions, it may fall within the definition of a drug and is consequently inadmissible (see Delineation of Cosmetic Products).

Delimitation & Borderline Manual

In some cases, the classification as a cosmetic product cannot be made without further ado. It must therefore be decided on a case-by-case basis by experts on the basis of function, composition, effect, product presentation, place of use or intended use.

Overlaps of cosmetics with other product groups such as pharmaceuticals, biocides, consumer goods, toys, foodstuffs or medical devices are possible. Cosmetics must comply with the legal definition of cosmetic products. There are also substances or mixtures that are not considered cosmetics, even though they serve to beautify. Thus, agents that are ingested, inhaled, injected or implanted into the human body are not cosmetic agents, as well as agents that have a predominantly different purpose, e.g. agents that serve predominantly as insect repellents. Also means for the care of animals are not cosmetic products according to the Cosmetics Regulation (EC) No. 1223/2009.

For more information on the delimitation of cosmetics from medicinal products and medical devices:

Persons wishing to place a product on the market may submit an application to the Federal Office for Safety in Health Care (BASG) pursuant to Section 1 (3b) of the German Medicines Act (AMG) for a determination as to whether that product falls within the definition of a medicinal product. The BASG also performs delineations of medical devices based solely on § 5a of the Austrian Medical Devices Act (BGBl. 657/1996 as amended, MPG). These orders are subject to a fee. The respective forms and details can be found here.

Criteria for delimitation

Important criteria for the delimitation can be found primarily in the decisions of the European Court of Justice (ECJ).

The European Commission has published a guide on borderline products in cosmetic products, which was developed together with the Member States and addresses different products. This is updated regularly: Borderline products manual on the scope of application of the Cosmetics Regulation (EC) No 1223/2009 (Art. 2(1)(a)) (September 2020, Version 5.2)

There are two documents on the distinction between hand cleansers and hand disinfectants

  • Guidance on the applicable legislation for leave-on hand cleaners and hand disinfectants
  • Borderline working document on leave-on hand gels November 2020 (available in 23 EU languages)

Further Guidance Documents on "Borderlines" can be found here.

Natural Cosmetics & Organic Cosmetics

Environmentally friendly sustainable production, preservation of biodiversity, protection of natural resources, application of high animal welfare standards, production using natural ingredients and simple manufacturing processes are increasingly demanded by consumers also for cosmetic products. In order to protect the interests and trust of consumers and to ensure fair competition through transparency, control and traceability, it was therefore appropriate to formulate principles and rules for the production and labeling of "organic as well as natural cosmetics".

At the European level, there are no uniform, legal definitions of the terms natural cosmetics and organic cosmetics. There are various natural cosmetic and organic quality labels based on private law guidelines. The underlying criteria vary, so that these products do not meet a uniform standard. This situation is confusing for both consumers and manufacturers.

Natural cosmetics

In Austria, the Austrian Food Codex ÖLMB (Codex Alimentarius Austriacus, abbreviated to Codex) summarizes what the consumer expects from natural cosmetics and what is generally accepted in the market.

Since 2008, this Codex chapter on natural cosmetics has been available and, if necessary, is revised by the Cosmetics Sub-Commission to meet the expectations of consumers. On Feb. 6, 2017, dehydroacetic acid was included as a permitted preservative. For the full text, see Codex Chapter B 33 Cosmetic Products, Subchapter: Natural Cosmetics.

Organic cosmetics

Organic cosmetics, regulated in the EU Quality Regulations Implementation Act (EU-QuaDG), Federal Law Gazette I No. 130/2015 and the corresponding directive, which has been valid since 1.12.2017 and replaces Codex Chapter A8 Section 6 Organic cosmetics.

With the entry into force of the EU-Quality Regulations Implementation Act (EU-QuaDG), the content of Codex Chapter A 8 "Agricultural products from organic production and derived products" was incorporated into the guideline drawn up by the Advisory Board for Organic Production in accordance with Section 13 of the EU-Quality Regulations Implementation Act (EU-QuaDG), Federal Law Gazette I No. 130/2015. The guideline - Agricultural products from organic production and derived products (RL Biologische Produktion) has the effect of an objectified expert opinion, as was already the case with the Austrian Food Book.

Labeling and advertising of cosmetic products produced according to the specifications of this section contain a clear reference to the production according to this guideline (produced according to the guideline of the Advisory Board for Organic Production "Biological Production, Section Biocosmetics").

Cosmetic companies placing their products on the market as organic cosmetics shall have their activities controlled by an organic control body already recognized for organic production under Regulation (EC) No 834/2007. The indication of the inspection body is required and the inspection body seal may be affixed, but the organic community logo may not, as the EU Organic Regulation does not apply to cosmetic products.

The natural ingredients in organic cosmetics are divided into natural substances of agricultural origin (plant and animal products) and those of non-agricultural origin (mineral raw materials and water).

Plant and animal ingredients of agricultural origin, must comply at least 95% with the provisions on organic production (Regulation (EC) No 834/2007 including implementing regulations). In addition, there must be a minimum organic content in relation to the final product (see table below). This is to counteract unjustified organic pricing, for example in the case of an aqueous solution with a "homeopathic" amount of a raw material in organic quality.

Category Organic minimum ingredient in % related to the finished product
Oils/water-free cleaning and care products 90
Perfumes/Eau de Parfum/Eau de Toilette 60
Emulsions for skin care (W/Ö) 30
Products with a mineral content greater than 80 10
Other products 20

Table: Biological minimum proportions in biocosmetics

Furthermore, rules have been laid down as to the proportion of aqueous mixtures such as distillates, extracts, hydrolates or even rediluted concentrates that may be used to calculate the organic content. Only the proportions actually obtained from plants are to be included in the organic content.

As in the case of natural cosmetics, only natural fragrances and aromatic substances that comply with the international standard ISO 9235 and the substances listed therein that have been isolated by physical methods may be used. The permitted nature-identical preservatives are also those that may be used in natural cosmetics. For a list on naturident preservatives, see Codex Chapter B 33 Cosmetic Products, Subchapter: Natural Cosmetics.

The full text of the directive can be found under: Directive - Agricultural products from organic production and derived products (RL Biologische Produktion) (Section 6 Biokosmetik).

Adverse effects

Article 2 of Regulation (EC) No 1223/2009 defines the following terms:

An undesirable effect is an adverse effect on human health attributable to the normal or reasonably foreseeable use of a cosmetic product.

A serious adverse effect is an adverse effect that results in temporary or permanent functional impairment, disability, hospitalization, congenital anomalies, imminent risk to life, or death.

According to Article 23, the responsible person, distributors and dealers must immediately report the occurrence of serious adverse effects to the competent authority. There is also an option for consumers and physicians to report serious adverse effects.

Reporting forms for whom? Report to
Notificationform A responsible person and the distributor competent authority
Notification form AT consumers and physicians competent food supervisory authority

Each form is accompanied by instructions for completion. The submitted form is to be used for both initial reporting and updates (follow-up, final conclusion).

The Guideline for Reporting Serious Adverse Effects describes in detail how to proceed and how to perform the causality assessment. Serious adverse reactions and adverse effects shall also be reported in the safety information and product information file (see Cosmetic Product Safety Assessment) (Article 11).

Furthermore, the responsible person shall ensure that existing data on undesirable effects and serious undesirable effects caused by the cosmetic product during its use are made readily available to the public by appropriate means (Article 21)

On the homepage of the Ministry of Social Affairs you can find more detailed information on the reporting system of serious undesirable effects as well as the contact points of the respective food inspectorate in your federal state.

For more information on Serious Undesirable Effects (SUE), please visit the European Commission's page on cosmetics.

Further information

Contact

Leitung

DI Gregor Özelt

Last updated: 19.10.2022

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