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.

Cosmetic products are regulated by the following laws:

• Regulation Regulation (EC) No 1223/2009 on cosmetic products applies to all cosmetic products made available in the EU and consists of 40 articles and 71 recitals, the 10 annexes are organised as follows:

• The Cosmetics Claims Regulation (EU) No. 655/2013 establishes common criteria for substantiating claims made in connection with cosmetic products. Guideline on Regulation (EU) No. 655/2013
• The Food and Consumer Protection Act (LMSVG) Federal Law Gazette I No. 13/2006 as amended regulates the requirements for cosmetic products and the associated responsibilities of business operators.
• The Cosmetics Implementing Regulation Federal Law Gazette II No. 330/2013 regulates the national regulations for the labelling of packaged and unpackaged cosmetic products.

Further guidelines and directives are:

The Austrian Food Codex (abbreviated to Codex) summarises, among other things, what is generally accepted in Austria. It is an objectivised expert opinion. It is used to publish technical terms, definitions, test methods and assessment principles as well as guidelines "for the manufacture and placing on the market of goods". Chapters relevant for cosmetics manufacturers are

• Cosmetic products B33: Natural cosmetics, rubbing alcohol, sunscreens
• Good manufacturing practice
• Organic cosmetics regulation: Directive - Agricultural products from organic production and derived products (RL Biologische Produktion)

• SCCS Notes of Guidance
• Opinions
• ÖNORMEN and CEN/ISO standards

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 ).

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 to the Commission by electronic means
• 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.

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.

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). Among other things, this involves a toxicological assessment of the ingredients, taking into account the exposure conditions (application concentration, application duration, application site).

The safety report (Art 10 + Annex I) is the centrepiece 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 the substances used
• Toxicological profile of the substances
• (serious) adverse effects

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

Safety assessor

Safety assessments may only be prepared by persons who fulfil the following requirements (in accordance with Cosmetics Regulation (EC) 1223/2009 Article 10, paragraph 2):

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

A list of food and cosmetics assessors working in Austria and authorised by the Ministry of Health in accordance with § 73 LMSVG can be found in the list of the BMASGPK (cosmetics assessors are authorised for group C Z 9 "Cosmetic products" and cosmetics safety assessors also require group F Z 13 "Toxicological evaluation of goods subject to the Food Safety and Consumer Protection Act - LMSVG" (limited to goods in group C Z 9 - cosmetic products)). Prerequisites and requirements for safety assessors and experts are explained on the website of the BMASGPK.

The following guidelines can be used as an aid for preparing the product information file or the safety report:

• Guidelines on Annex I "Safety report for cosmetic products" of Regulation (EC) No 1223/2009
• AGES form for the preparation of a product information file (version 6)
• Revision of the Notes of Guidance

Ensuring microbiological quality is the responsibility of the person in charge, advised by their safety assessor. The state of the art for the microbiological quality of finished cosmetic products is defined both in ÖNORM EN ISO 17516: 2015 01 01 Cosmetic products - Microbiology - Microbiological limits (ISO 17516:2014) and in the SCCS Notes of guidance for the testing of cosmetic ingredients and their safety evaluation - 12th revision - Public Health, SCCS/1647/22, Corrigendum 2, APPENDIX 9: GUIDELINE ON MICROBIOLOGICAL QUALITY OF THE FINISHED COSMETIC PRODUCT).

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 viable count for aerobic mesophilic microorganisms: not more than 10² colony-forming units per gram or millilitre (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 can be jeopardised by a large number of pathogens. The indicator microorganisms described below serve as an orientating assessment. If there is sufficient suspicion, other pathogens should also be tested for on a case-by-case basis. The following specific microorganisms must not be detectable: Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Escherichia coli.

Preservation

The Cosmetics Regulation (EC) 1223/2009 stipulates that in the safety report Part A (according to Annex I, Z3), results from preservation challenge tests are also used to assess the microbiological quality. See also"Challenge testing" in the SCCS Notes of Guidance, 12th Revision, Appendix 9. Further information on preservation can be found under"Cosmetics Info & Recommendations"

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 a number of publications and books, which can be found here.

The Industrieverband für Körperpflege- und Waschmittel e. V. (IKW) has published a very detailed guide for Microbiological Quality Management (MQM) of cosmetic products (IKW 1998).

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

The legal obligation to apply the principles of "good manufacturing practice" arises from Article 8 of the Cosmetics Regulation (EC) No. 1223/2009.

You can find out how to implement good manufacturing practices in the following documents and guidelines:

• Cosmetics - Good Manufacturing Practices (GMP) - Guidelines on Good Manufacturing Practices (EN ISO 22716:2007) or Cosmetics - GMP - Guidelines on Good Manufacturing Practices (ÖNORM EN ISO 22716)
• Guideline of the Austrian Codex Commission for the manufacture of cosmetic products in accordance with the principles of "Good Manufacturing Practice" (Cosmetics GMP). In preparing this guideline, some definitions of terms and some points of content were taken from the "Cosmetics GMP Guideline on Good Manufacturing Practices" ISO/TC 217 N78, which is recognised at international level.

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

• DGK Handbook"Industrial Hygiene in Cosmetics" - 2nd revised edition 2019. Verlag für Chemische Industrie, H. Ziolkowsky GmbH, D-86470 Thannhausen/Burg, ISBN 978-3-87846-07-8

The requirements for a microbiologically and hygienically flawless product are constantly increasing. This book has been written from a microbiological and hygienic perspective and is intended to provide practitioners in companies, such as plant managers, developers and those responsible for quality assurance and testing, as well as experts from other disciplines, with procedural instructions and practical advice on the implementation of industrial hygiene. All important aspects of industrial hygiene are summarised here, providing a good overview of the current state of knowledge in the field.

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):

According to Cosmetics Regulation (EC) No. 1223/2009 (Article 19), 24 ingredients (Annex III) must also be declared due to their allergenic potential.

It is not sufficient to declare these 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).

The following two allergenic fragrances have been included in the Prohibited List, Annex II, and may no longer be used in cosmetic products:

*) The fragrance "hydroxyisohexyl 3-cyclohexene carboxaldehyde" (Annex II/ No. 1380) has been banned due to its sensitising properties. This substance has been banned since 23 August 2021 (Regulation (EU) No. 2017/1410)

**) Butylphenyl methylpropional (Annex II/ No. 1666) was banned on 1 March 2022 due to its classification as CMR (reprotoxic) (Regulation (EU) No. 2021/1902)

The new regulations on fragrance labelling can be found here.

Manufacturers are granted a transitional period of three or five years to change the information on cosmetic products:

• For all new products (placing on the market): 3 years (31 July 2026)
• For all products already on the market (making available on the market): 5 years (31 July 2028)

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.

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

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

If a cosmetic product advertises with statements that the product is intended to cure or alleviate or prevent human diseases or pathological complaints, it may fall under the definition of a medicinal product and is therefore not permitted (see delimitation of cosmetic products).

According to §18 para. 2 in conjunction with §5 para. 3 LMSVG, it is prohibited to attribute to a cosmetic product the properties of preventing, treating or curing a human disease or to create the impression of such an effect when placing it on the market or in advertising. The only exceptions to this prohibition are claims that refer to a cosmetic intended use in accordance with the definition of cosmetic products under Section 3 Z8 LMSVG.

According to the definition, cosmetic products are used externally to cleanse, perfume, change the appearance, influence body odour, protect the skin or keep it in good condition.

According to the Manz Commentary, illness is to be understood as a temporally and intensely variable disturbance of the normal condition (health) of the body. For example, inflammation is to be understood as a disturbance of the normal condition (health) of the body. They do not relate to a cosmetic purpose and at least give the impression of treating a pathological condition.

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.

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 guideline on borderline products for cosmetic products, which was developed together with the Member States and deals with different products. This is updated regularly: MANUAL ON THE SCOPE OF APPLICATION OF THE COSMETICS DIRECTIVE 76/768/EEC (ART. 2(1)(A)) VERSION 5.5 (JUNE 2025)

There are two documents on the distinction between hand cleaners and hand sanitisers

• 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.

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.

In Austria, the Austrian Food Codex ÖLMB (Codex Alimentarius Austriacus, in short: Codex) summarizes what the consumer expects from natural cosmetics or what concerns the general perception of 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, 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 December 2017 and replaces Codex Chapter A8 Section 6 Organic Cosmetics.

With the entry into force of the EU Quality Schemes 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 Schemes Implementation Act (EU-QuaDG), Federal Law Gazette I No. 130/2015. As with the Austrian Food Codex, the Directive - Agricultural Products from Organic Production and Derived Products (RL Biologische Produktion) has the effect of an objectified expert opinion.

Labelling and advertising for cosmetic products that have been produced in accordance with the requirements of this section contain a clear reference to production in accordance with this directive (produced in accordance with the directive of the Advisory Board for Organic Production "Organic Production, Section Organic Cosmetics").

Cosmetics companies that place their products on the market as organic cosmetics must have their activities inspected by an organic inspection body already recognised for organic production in accordance with Regulation (EC) No. 834/2007. The inspection body must be named 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 with at least 95% of the provisions on organic/ecological production (Regulation (EC) No. 834/2007 including implementing regulations). In addition, there must be a minimum organic content in relation to the end product (see table below). This is intended to counteract unjustified organic pricing, for example in the case of an aqueous solution with a "homeopathic" quantity of a raw material in organic quality.

Table: Minimum biological content in organic cosmetics

Furthermore, rules have been laid down as to what proportion of aqueous mixtures such as distillates, extracts, hydrolates or even re-diluted concentrates may be used to calculate the organic content. Only the proportion actually obtained from plants should be counted as organic.

As with natural cosmetic products, only natural fragrances and flavourings 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. A list of nature-identical preservatives can be found under Codex chapter B 33 Cosmetic products, subchapter: Natural cosmetics.

The full text of the directive can be found at: Directive - Agricultural products from organic production and derived products (Directive on organic production) (Section 6 Organic cosmetics).

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

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

A serious adverse reaction is an adverse reaction that results in temporary or permanent functional impairment, disability, hospitalisation, congenital anomalies, imminent danger to life or death.

According to Article 23, the responsible person and distributors must immediately report the occurrence of serious adverse effects to the competent authority. Consumers and doctors also have the option of reporting serious undesirable effects.

Completion instructions are attached to each form. The submitted form is to be used both for the initial notification and for updates (follow-up, final conclusion).

The guideline for the reporting of serious adverse reactions describes in detail how to proceed and how to carry out the causality assessment. Serious undesirable effects and adverse reactions must also be reported in the safety information and product information file (see safety assessment of cosmetic products) (Article 11).

Furthermore, the responsible person shall ensure that existing data on adverse reactions and serious adverse reactions caused by the cosmetic product when used are made readily available to the public by appropriate means (Article 21)

Consumer complaints and products on (serious) undesirable effects can be submitted to the respective food supervisory authority of the federal states in your federal province.

Further information on Serious Undesirable Effects (SUE) can be found on the European Commission's page on cosmetics.