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 in 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 BGBl. 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 bzw. CEN/ISO-Normen

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 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."

A list of food and cosmetic safety assessors:in accordance with § 73 LMSVG working in Austria and authorized by the Ministry of Health can be found in the list of the BMSGPK (cosmetic safety assessors:in are authorized for group C Z 9 "Cosmetic products" and cosmetic safety assessors:in additionally require group F Z 13 "Toxicological assessment of goods subject to the Food Safety and Consumer Protection Act - LMSVG" (restricted to goods of group C Z 9 - cosmetic products) ). Prerequisites and requirements for safety assessors and evaluators are explained on the page of the BMSGPK.

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

• Guidance on Annex I "Cosmetic Product Safety Report" of Regulation (EC) No 1223/2009.
• AGES form for the preparation of a product information file (version 6)
• Revision of the Notes of Guidance

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

The 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".

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).

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:

• 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 according to the principles of "Good Manufacturing Practices" (Cosmetic GMP). In the preparation of this guideline, some definitions of terms and some content points of "Cosmetics-GMP-Guideline on Good Manufacturing Practices" ISO/TC 217 N78, which is recognized at the international level, were used.

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.

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 ), 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).

*) 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 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 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).

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 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.

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 1.12.2017 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" has been incorporated into the Guideline prepared 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.

Table: Biological minimum proportions in organic cosmetics

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).

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.

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.