3. European Union legislation for essential oils

The relevant legislative rules on essential oils are referred to as 'general regulations' (known as REACH and CLP) and 'specific regulations'. Analysed below are general aspects of the principle regulations pertaining to essential oils and those related to individual product categories considered in this chapter (flavourings for food, cosmetics, and additives for animal nutrition).

#### 3.1. General regulations for essential oils

2.3. Demand for essential oils

116 Potential of Essential Oils

2.4. Consumption of essential oils

There is a lack of data and information about market demand for essential oils. Demand comes principally from the following markets: food and beverage (35%), fragrances, cosmetics and aromatherapy (29%), household (16%), and pharmaceutical (15%) [3]. Food and beverage is the largest segment in terms of market share, in part due to the recognition that essential oils contain health benefits as the natural ingredients that impart the essence of the source from which they have been derived. Various essential oils used by manufacturers include oils from orange, lemon, and lime. Orange oil is mainly used in foods and beverages to impart a citrus flavour and freshness to the final product. As consumers have become increasingly aware of the health benefits of essential oils, preferences for food and beverage products containing these oils as additives have grown. The global essential oils market has also been driven by the growth in demand for natural and organic hygiene products due to expanding attention to health problems among consumers. Natural flavour and fragrance demand in cosmetics, perfumes, and thermal and relaxation applications are expected to fuel demand for essential oils. Essential oils and oleoresins are not only used in the food processing and industrial seasoning sector in particular but also are important in the flavouring and perfume industry. Globally, operating flavours and fragrance manufacturers are among the main buyers of essential oils. Their sales provide an indication of developments in their market and subsequent demand for essential oils. Between 2012 and 2016, global sales of flavour and fragrance manufacturers increased by 7% to €25B. The growing demand for natural cosmetics and natural flavourings is an important driver of this sales growth. The top 11 companies represent 78% of total sales; the three major flavour and fragrance manufacturers are Givaudan, Firmenich, IFF, which as a threesome account for 46% of all sales (Figure 8). In 2016, Frutarom

and Mane, SA, continued to accelerate their growth through various acquisitions [38].

Consumers are becoming more attentive to their health. Therefore, food and beverage manufacturers are looking to replace unhealthy ingredients that improve the texture of food with natural thickeners. Growing consumer preference for natural products has led to the development of innovative applications in personal care and beauty products as well. Rapid industrialisation and increasing disposable consumer incomes are the other major factors driving essential oil production in the developing countries of China, India, Vietnam, and Thailand. The majority of consumers by country, according to the data provided by Directorate Marketing of the USDA, are in the US (40%), Western Europe (30%), and Japan (7%) [39]. Sales of essential oils are closely tied to consumer education—the more consumers understand how and why to use essential oils, the greater the demand and sales growth. Aromatherapy is a prime example of how market sales are influenced by sector operations. The aromatherapy market relies on both professional (aromatherapists) and personal (individual consumers) utilisation for its retail purchases. In a 2013 survey of trends in the US aromatherapy market, over 62% of professional therapists developed their own products for re-sale in addition to their professional use. Almost all aromatherapists are self-employed, running their own small practices, but many also play roles in the educational (40%) and retail/wholesale (26%) ends of

REACH Regulation (Regulation (EC) No 1907/2006 of 18 December 2006) [40–44] concerns the registration, evaluation, authorisation, and restriction of chemicals (in short, 'substances'). It explicitly references the 'Sustainable Development Implementation Plan' (Johannesburg World Summit), which foresees that by 2020 the production and use of chemicals will be such as to minimise the harmful effects on human and environmental health, as required by the Strategic Approach to the International Management of Chemical Substances (SAICM), Dubai, 6 February 2006. REACH applies to all individual chemicals in preparations, contained in products manufactured or imported in annual quantities above a tonne. Of course, many compounds are excluded from the regulation: radioactive substances, waste, substances subject to customs control, as well as substances used in human or veterinary medicine, in animal foodstuffs, additives in foodstuffs for human consumption, flavourings for human consumption, additives for animal food, and additives for final preparations for end users of medicines, cosmetics products, and substances for which the available data indicate minimal risk exits. A broad category excluded from REACH are substances subject to customs control (in transit or re-export) transported by rail, road, ship, or air. Creation of the Regulation arose from multiple objectives: (1) to protect human and environmental health from the use of chemical products; (2) to encourage or guarantee replacement of dangerous substances with less risky substances or technologies, to incentivise transition to more technically or economically viable alternatives; (3) to instil manufacturers and importers with the responsibility of understanding and managing the risks associated with the use of these substances; (4) to allow free circulation of substances on the EU market through similar requirements in EU countries; (5) to improve competitiveness and foster innovation in the EU chemical industry; (6) to promote the use of alternative methods to assess the substance hazards and limit animal testing. To collect the data and then make it available and useful to interested parties, the Regulation established the 'European Chemicals Agency' (ECHA) to collect, manage, and control manufacturer and importer substance registration. Collected substance and use information may be accessed to assist with activities related to implementation EU rules on voluntary labelling or to guide the EU Commission when they are revising rules concerning such substances, voluntary instruments, or community trademarks. The registration process starts with an assignment of a presentation number (identifier comprising a number and date), plus payment of a tariff. It finishes when the registrant receives notification of registration for the same identifier. The Agency is obliged to notify the EU member state in which the manufacturing site (or registered office of the manufacturer) is located that the following are available in the Agency database: registration dossier, registration date, completeness check results, and other manufacturerprovided information. The manufacturer or importer must update the registration database as needed (e.g. changes in legal status, substance composition, labelling, etc.). The ECHA website [44] hosts all registered substances statistical data under three groupings 'Full Registration', 'Transported Isolated Intermediates' and 'On-site Isolated Intermediate', for the European Economic Area (EEA) that includes the EU member states, plus Iceland, Norway and Liechtenstein. The number of registrations from 1 June 2008 and forward ==== - categorized as 'Detailed Registration Statics' - is 14,640, of which 75% are 'Full registrations' that represent 6,763 'Substances'. The difference between Registrations and Substances is due to "In one registration dossier any combination of one up to three different types can be covered". The bulk of registrations is made by large enterprises (85%), as compared to small and medium enterprises (SME). In terms of registrant, 43% of registrations are done by importers, 28% by a representative of a non-EU manufacturers, 24% by manufacturers, and 5% by manufacturers/ importers. Essential oils are not among the substances most registered by EEA countries; rather, these lists contain the likes of ethanol, propane-1,2-diol, silicon dioxide, and so on. The

second 'general regulation' of interest for essential oils is known as Regulation Classification, Labelling, Packaging (CLP), Regulation (CE) N. 1272/2008 16 December 2008 on classification, labelling, and packaging of substances and mixtures [45]. The law became effective on 1 June 2015 and had several objectives as follows: (1) to determine if a substance or mixture has properties that classify it as dangerous; (2) to ensure high levels of human and environmental health protection; (3) to harmonise classification, labelling, and packaging criteria; (4) to facilitate free circulation of substances, mixtures, and articles; (5) to create a single set of rules to oversee the safe transport of these substances; (6) to produce a catalogue of substances from the classification and labelling of chemicals based on the classification of chemicals used by the United Nations. The regulation requires manufacturers, importers, and downstream users to classify, label, and package dangerous substances or mixtures before market placement, based on a 'self-classification' by manufacturers, importers, and other related parties. Comparison of information on the hazard(s) of a given substance/mixture to information on the dangers established by the criteria of the CLP Regulation results in a class and category danger assignment that correlates with the related physical, human, and/or environmental health hazard(s). Hazards must be communicated and maintained via appropriate labelling throughout the supply and production chain to market for substances classified as dangerous, mixtures containing one or more substances classified as dangerous beyond a specified threshold and for articles having explosive properties. Label elements—pictographs, warnings, and standard declarations of danger, prevention, reaction, storage, and disposal—are precisely defined for each hazard class and category. In addition, the name, address, and telephone number of the supplier are provided. Packaging must be such so as to prevent escape of the contents, not attract the attention or curiosity of children, and look similar to that typically used for food, animal feed, or cosmetics. Classification and labelling of certain hazardous substances are standardised across the EU (CLH) and are found in Annex 6 of regulation classifications. The following situations allow any manufacturer, importer, downstream user, or member state to propose standard classification and labelling: (1) when a substance is carcinogenic, mutagenic, or toxic to reproduction or respiration; (2) when classification of a substance is necessary at the European level for other hazardous classes; (3) when it is necessary to add one or more hazardous classes to an existing item. Manufacturers and importers are fully responsible to keep current any classification and labelling information for substances they place on the market in a specific C&L inventory maintained by ECHA. The regulation is also the basis for legislation that man-

Essential Oils: Market and Legislation http://dx.doi.org/10.5772/intechopen.77725 119

ages chemical risks.

3.2.1. Flavourings for food

3.2. Regulations inherent to some uses of essential oils

The following paragraphs describe the principal contents of regulations inherent to flavourings, cosmetics, and additives for animal nutrition. In general, regulations aim to protect consumer health and to improve the free circulation of stuffs in the EU market through common rules.

Regulation (EC) No 1334/2008 of 16 December 2008 is the centrepiece legislation 'on flavourings and certain food ingredients with flavouring properties for use in and on foods' [46].

second 'general regulation' of interest for essential oils is known as Regulation Classification, Labelling, Packaging (CLP), Regulation (CE) N. 1272/2008 16 December 2008 on classification, labelling, and packaging of substances and mixtures [45]. The law became effective on 1 June 2015 and had several objectives as follows: (1) to determine if a substance or mixture has properties that classify it as dangerous; (2) to ensure high levels of human and environmental health protection; (3) to harmonise classification, labelling, and packaging criteria; (4) to facilitate free circulation of substances, mixtures, and articles; (5) to create a single set of rules to oversee the safe transport of these substances; (6) to produce a catalogue of substances from the classification and labelling of chemicals based on the classification of chemicals used by the United Nations. The regulation requires manufacturers, importers, and downstream users to classify, label, and package dangerous substances or mixtures before market placement, based on a 'self-classification' by manufacturers, importers, and other related parties. Comparison of information on the hazard(s) of a given substance/mixture to information on the dangers established by the criteria of the CLP Regulation results in a class and category danger assignment that correlates with the related physical, human, and/or environmental health hazard(s). Hazards must be communicated and maintained via appropriate labelling throughout the supply and production chain to market for substances classified as dangerous, mixtures containing one or more substances classified as dangerous beyond a specified threshold and for articles having explosive properties. Label elements—pictographs, warnings, and standard declarations of danger, prevention, reaction, storage, and disposal—are precisely defined for each hazard class and category. In addition, the name, address, and telephone number of the supplier are provided. Packaging must be such so as to prevent escape of the contents, not attract the attention or curiosity of children, and look similar to that typically used for food, animal feed, or cosmetics. Classification and labelling of certain hazardous substances are standardised across the EU (CLH) and are found in Annex 6 of regulation classifications. The following situations allow any manufacturer, importer, downstream user, or member state to propose standard classification and labelling: (1) when a substance is carcinogenic, mutagenic, or toxic to reproduction or respiration; (2) when classification of a substance is necessary at the European level for other hazardous classes; (3) when it is necessary to add one or more hazardous classes to an existing item. Manufacturers and importers are fully responsible to keep current any classification and labelling information for substances they place on the market in a specific C&L inventory maintained by ECHA. The regulation is also the basis for legislation that manages chemical risks.

#### 3.2. Regulations inherent to some uses of essential oils

The following paragraphs describe the principal contents of regulations inherent to flavourings, cosmetics, and additives for animal nutrition. In general, regulations aim to protect consumer health and to improve the free circulation of stuffs in the EU market through common rules.

#### 3.2.1. Flavourings for food

as to minimise the harmful effects on human and environmental health, as required by the Strategic Approach to the International Management of Chemical Substances (SAICM), Dubai, 6 February 2006. REACH applies to all individual chemicals in preparations, contained in products manufactured or imported in annual quantities above a tonne. Of course, many compounds are excluded from the regulation: radioactive substances, waste, substances subject to customs control, as well as substances used in human or veterinary medicine, in animal foodstuffs, additives in foodstuffs for human consumption, flavourings for human consumption, additives for animal food, and additives for final preparations for end users of medicines, cosmetics products, and substances for which the available data indicate minimal risk exits. A broad category excluded from REACH are substances subject to customs control (in transit or re-export) transported by rail, road, ship, or air. Creation of the Regulation arose from multiple objectives: (1) to protect human and environmental health from the use of chemical products; (2) to encourage or guarantee replacement of dangerous substances with less risky substances or technologies, to incentivise transition to more technically or economically viable alternatives; (3) to instil manufacturers and importers with the responsibility of understanding and managing the risks associated with the use of these substances; (4) to allow free circulation of substances on the EU market through similar requirements in EU countries; (5) to improve competitiveness and foster innovation in the EU chemical industry; (6) to promote the use of alternative methods to assess the substance hazards and limit animal testing. To collect the data and then make it available and useful to interested parties, the Regulation established the 'European Chemicals Agency' (ECHA) to collect, manage, and control manufacturer and importer substance registration. Collected substance and use information may be accessed to assist with activities related to implementation EU rules on voluntary labelling or to guide the EU Commission when they are revising rules concerning such substances, voluntary instruments, or community trademarks. The registration process starts with an assignment of a presentation number (identifier comprising a number and date), plus payment of a tariff. It finishes when the registrant receives notification of registration for the same identifier. The Agency is obliged to notify the EU member state in which the manufacturing site (or registered office of the manufacturer) is located that the following are available in the Agency database: registration dossier, registration date, completeness check results, and other manufacturerprovided information. The manufacturer or importer must update the registration database as needed (e.g. changes in legal status, substance composition, labelling, etc.). The ECHA website [44] hosts all registered substances statistical data under three groupings 'Full Registration', 'Transported Isolated Intermediates' and 'On-site Isolated Intermediate', for the European Economic Area (EEA) that includes the EU member states, plus Iceland, Norway and Liechtenstein. The number of registrations from 1 June 2008 and forward ==== - categorized as 'Detailed Registration Statics' - is 14,640, of which 75% are 'Full registrations' that represent 6,763 'Substances'. The difference between Registrations and Substances is due to "In one registration dossier any combination of one up to three different types can be covered". The bulk of registrations is made by large enterprises (85%), as compared to small and medium enterprises (SME). In terms of registrant, 43% of registrations are done by importers, 28% by a representative of a non-EU manufacturers, 24% by manufacturers, and 5% by manufacturers/ importers. Essential oils are not among the substances most registered by EEA countries; rather, these lists contain the likes of ethanol, propane-1,2-diol, silicon dioxide, and so on. The

118 Potential of Essential Oils

Regulation (EC) No 1334/2008 of 16 December 2008 is the centrepiece legislation 'on flavourings and certain food ingredients with flavouring properties for use in and on foods' [46]. It aims to protect human health and to allow free movement of food on the EU internal market. For regulation purposes, 'flavouring' is a product that is not consumed as such, but is added to food to modify its taste or aroma and is manufactured or derived from substances of plant, animal, or microbiological origin. 'Natural flavourings' are substances normally present in nature; they fall outside the scope of the legislation in the following cases: raw foods, substances with sweet, sour, or salty tastes, and mixtures like spices or herbal teas. Instead, the regulation targets flavourings used in and on foods, flavouring food ingredients, foods containing flavourings, and the basic materials for their preparation. According to Article 4 of the regulation, "flavourings/flavouring ingredients may be used only if they do not present a risk to the health of the consumer on the basis of the available scientific data and if their use does not mislead the consumer". The safety requirement demands that a risk assessment be made prior to the use as envisaged; a complementary section of the regulation, Article 8, indicates the flavouring aromas and food ingredients excluded from risk assessment and authorisation. Risks are assessed under a Commission of the Food Safety Authority (EFSA). Aromas and base material flavourings that are evaluated and authorised by the Commission are added to the EU list that allows their market entry as such or for food use. Articles 14, 15, 16, and 17 specify label standards for intermediate users and end-users sales. For market placement for intermediate users, the package or container must display aroma, food, name, company name, and address of the producer, while flavourings for final consumer use can be placed on the market only if 'for food' is present on the label, easily visible, legible, and indelible. When the product is 'natural', additional provisions apply. Finally, Article 20 of the regulation expects member states to create monitoring systems for flavouring consumption use and information collection to the Authority and Commission.

cosmetic presents 'non-conformities', the Responsible Person must make the cosmetic compliant, withdraw it from the market, or recall it from all member states where it is available. The label must be void of words or other means that suggests characteristics or functions the product does not possess. The label must include the company name and address of the Responsible Person; country of origin of imported products; nominal content for packaging by weight or volume; expiration date for products properly stored; precautions for use; the manufacturing lot number or reference allowing identification of the product; ingredient list, substances, or mixtures used intentionally during manufacture. In terms of product claims, the regulation indicates that the Commission should define an 'Action Plan' to standardise the declarations applied to cosmetics and that it should set common criteria for the use of those declarations. A centralised information source provides distributor names, label dispatch, and product photographs and creates a master registration list for all EU member states. Animal product testing is under replacement in the EU with alternative methods. Animal testing is already prohibited for finished products, ingredients, and combinations of ingredients. Consequently, EU cosmetics market placement of products with formulation or ingredients or combination of ingredients is not permitted. Member states are responsible for verifying the application of manufacturing principles through ISO 22716 'Guidelines on Good Manufacturing Practices' (GMP). Member states must also monitor the market with information provided by sector operators, random testing, and ingredient lists aimed at allergic sensitivities, in

Essential Oils: Market and Legislation http://dx.doi.org/10.5772/intechopen.77725 121

There are two regulations governing additives for animal nutrition: one is Regulation (EC) No 1831/2003 of 22 September 2003 on additives for use in animal nutrition and the other is Regulation (EC) No 429/2008 of 25 April 2008 that details the rules for the implementation of the former regulation (Regulation (EC) 1831/2008) [49–51]. Article 2 of the regulation defines feed additives as "substances, micro-organisms or preparations, other than feed and premixtures which are intentionally added to animal feed or water in order to perform, in particular, one or more of the functions". Five different categories of additives are identified: technological, organoleptic, nutritional, zoo-technical, coccidiostatic, and histomonostatic. The first three categories include 'functional groups' as highlighted in Annex I of the regulation itself. It clearly states that as of 1 January 2006, antibiotics are prohibited as feed additives and that only additives authorised according to Regulation 1831/2003 and its specific Authorisation Regulation can be placed on the market, used, and transformed. The regulation generally limits market readiness or use of pre-mixes, defined as "mixtures of feed additives or mixtures of one or more feed additives with feed materials or water, used as a carrier, not intended for direct feeding to animals" in the same way as described above. Additives mixtures do not need authorisation under the following circumstances: the operator complies with the requirements of Regulation (EC) No 183/2005, the additive mixture is produced only by authorised additives, and the conditions of use foreseen for each single additive are respected; the chemical, physical and biological compatibility between mixture components is ensured relative to the expected effects. The regulation also provides indications regarding labelling (Article 16). Producers and/or those who place additives and pre-mixtures of additives on the market must be

particular.

3.2.3. Additives for animal nutrition

#### 3.2.2. Cosmetics

The foundational legislation for the cosmetics sector is Regulation (EC) No 1223/2009 of 30 November 2009 [47, 48]. Essential oils are contained in many cosmetics (e.g. creams or body care products). Rules regulating the use of essential oils in cosmetics aim to balance EU market placement while considering the technological innovation in the sector. Another objective is to guarantee high quality to protect the health and safety of consumers. The regulation became effective on 1 July 2013. It contains many essential aspects: 'Basic definition set' (cosmetics, substances, manufacturers) and of the Responsible Person; specifications for labelling and advertising claims; indications for centralised notification; rules concerning animal testing; manufacturing standards (GMP); responsibilities of member states for market surveillance; indications relating to carcinogenic, mutagenic and toxic for reproduction (CMR) substances and to nano-materials. The Responsible Person (natural or legal person) is obligated to meet the regulatory requirements for each cosmetic product on the market. The individual is held to both technical and health responsibilities and must submit all security documentation from Information Documentation to Safety Reports (Annex I of the Regulation) to Safety Assessments. In addition, organised 'surveillance of cosmetics' and health authority reporting must be established. There must be a guarantee of traceability to identify the links within the supply and distribution chain for three years following the date of distribution availability. If a cosmetic presents 'non-conformities', the Responsible Person must make the cosmetic compliant, withdraw it from the market, or recall it from all member states where it is available. The label must be void of words or other means that suggests characteristics or functions the product does not possess. The label must include the company name and address of the Responsible Person; country of origin of imported products; nominal content for packaging by weight or volume; expiration date for products properly stored; precautions for use; the manufacturing lot number or reference allowing identification of the product; ingredient list, substances, or mixtures used intentionally during manufacture. In terms of product claims, the regulation indicates that the Commission should define an 'Action Plan' to standardise the declarations applied to cosmetics and that it should set common criteria for the use of those declarations. A centralised information source provides distributor names, label dispatch, and product photographs and creates a master registration list for all EU member states. Animal product testing is under replacement in the EU with alternative methods. Animal testing is already prohibited for finished products, ingredients, and combinations of ingredients. Consequently, EU cosmetics market placement of products with formulation or ingredients or combination of ingredients is not permitted. Member states are responsible for verifying the application of manufacturing principles through ISO 22716 'Guidelines on Good Manufacturing Practices' (GMP). Member states must also monitor the market with information provided by sector operators, random testing, and ingredient lists aimed at allergic sensitivities, in particular.

#### 3.2.3. Additives for animal nutrition

It aims to protect human health and to allow free movement of food on the EU internal market. For regulation purposes, 'flavouring' is a product that is not consumed as such, but is added to food to modify its taste or aroma and is manufactured or derived from substances of plant, animal, or microbiological origin. 'Natural flavourings' are substances normally present in nature; they fall outside the scope of the legislation in the following cases: raw foods, substances with sweet, sour, or salty tastes, and mixtures like spices or herbal teas. Instead, the regulation targets flavourings used in and on foods, flavouring food ingredients, foods containing flavourings, and the basic materials for their preparation. According to Article 4 of the regulation, "flavourings/flavouring ingredients may be used only if they do not present a risk to the health of the consumer on the basis of the available scientific data and if their use does not mislead the consumer". The safety requirement demands that a risk assessment be made prior to the use as envisaged; a complementary section of the regulation, Article 8, indicates the flavouring aromas and food ingredients excluded from risk assessment and authorisation. Risks are assessed under a Commission of the Food Safety Authority (EFSA). Aromas and base material flavourings that are evaluated and authorised by the Commission are added to the EU list that allows their market entry as such or for food use. Articles 14, 15, 16, and 17 specify label standards for intermediate users and end-users sales. For market placement for intermediate users, the package or container must display aroma, food, name, company name, and address of the producer, while flavourings for final consumer use can be placed on the market only if 'for food' is present on the label, easily visible, legible, and indelible. When the product is 'natural', additional provisions apply. Finally, Article 20 of the regulation expects member states to create monitoring systems for flavouring consumption use and information collection to the

The foundational legislation for the cosmetics sector is Regulation (EC) No 1223/2009 of 30 November 2009 [47, 48]. Essential oils are contained in many cosmetics (e.g. creams or body care products). Rules regulating the use of essential oils in cosmetics aim to balance EU market placement while considering the technological innovation in the sector. Another objective is to guarantee high quality to protect the health and safety of consumers. The regulation became effective on 1 July 2013. It contains many essential aspects: 'Basic definition set' (cosmetics, substances, manufacturers) and of the Responsible Person; specifications for labelling and advertising claims; indications for centralised notification; rules concerning animal testing; manufacturing standards (GMP); responsibilities of member states for market surveillance; indications relating to carcinogenic, mutagenic and toxic for reproduction (CMR) substances and to nano-materials. The Responsible Person (natural or legal person) is obligated to meet the regulatory requirements for each cosmetic product on the market. The individual is held to both technical and health responsibilities and must submit all security documentation from Information Documentation to Safety Reports (Annex I of the Regulation) to Safety Assessments. In addition, organised 'surveillance of cosmetics' and health authority reporting must be established. There must be a guarantee of traceability to identify the links within the supply and distribution chain for three years following the date of distribution availability. If a

Authority and Commission.

3.2.2. Cosmetics

120 Potential of Essential Oils

There are two regulations governing additives for animal nutrition: one is Regulation (EC) No 1831/2003 of 22 September 2003 on additives for use in animal nutrition and the other is Regulation (EC) No 429/2008 of 25 April 2008 that details the rules for the implementation of the former regulation (Regulation (EC) 1831/2008) [49–51]. Article 2 of the regulation defines feed additives as "substances, micro-organisms or preparations, other than feed and premixtures which are intentionally added to animal feed or water in order to perform, in particular, one or more of the functions". Five different categories of additives are identified: technological, organoleptic, nutritional, zoo-technical, coccidiostatic, and histomonostatic. The first three categories include 'functional groups' as highlighted in Annex I of the regulation itself. It clearly states that as of 1 January 2006, antibiotics are prohibited as feed additives and that only additives authorised according to Regulation 1831/2003 and its specific Authorisation Regulation can be placed on the market, used, and transformed. The regulation generally limits market readiness or use of pre-mixes, defined as "mixtures of feed additives or mixtures of one or more feed additives with feed materials or water, used as a carrier, not intended for direct feeding to animals" in the same way as described above. Additives mixtures do not need authorisation under the following circumstances: the operator complies with the requirements of Regulation (EC) No 183/2005, the additive mixture is produced only by authorised additives, and the conditions of use foreseen for each single additive are respected; the chemical, physical and biological compatibility between mixture components is ensured relative to the expected effects. The regulation also provides indications regarding labelling (Article 16). Producers and/or those who place additives and pre-mixtures of additives on the market must be registered or recognised per Regulation (EC) 183/2005 guidelines. Finally, it should be noted that the authorisation for a new additive (Article 4) or for a new use requires submission of an application to the European Commission—Directorate General for Health and Consumer Protection (DG SANTE), that demonstrates compliance with paragraph 2 of Article 5 and at least one of the characteristics named in paragraph 3 of Article 5. Regulation (EC) No 429/2008 contains preparation and presentation rules for additive application, evaluation, and authorisation. Completed applications are forwarded to the Commission, which sends it to EFSA and to the VII-DGSAF Office of the Ministry of Health for evaluation by the member state Ministry of Health and Community Laboratory. At the end of the evaluation, EFSA issues an opinion (Article 8), which is sent to the EU Commission for preparation of an ad hoc regulation. Each authorised additive is entered in a community register with authorisation date, expiration date, and the relative Authorisation Regulation.

substances in the EU market through similar requirements in EU countries; to improve competitiveness and foster innovation in the EU chemical industry; to promote the use of alternative methods to assess the substance hazards and limit animal testing. All substances subject to regulation (waste excluded) must be registered and authorised, as described by these regulations. The European Chemical Agency, established by REACH, oversees application and authorisation for registry admission and ultimate entry into the marketplace. CLP regulates substance and mixture classification, labelling, and packaging. It determines if the properties of a substance or mixture are dangerous. It also ensures high levels of human and environmental health protection, a standard classification schema, labelling and packaging criteria for EU member states, and a catalogue of substances consistent with chemical classification used by the United Nations. Pre-market entry, dangerous substances, and mixtures must be 'selfclassified' by manufacturers, importers, and other related parties (downstream users) into a class and category of danger correlated with the related physical, human, and/or environmental health hazard(s). This regulation also details precise information and pictograms for substance/mixture label placement. Specific regulations for flavourings/flavouring ingredients are limited for those not of risk to consumer health on the basis of available scientific data and as long as their use does not mislead the consumer. Risks are assessed under a commission of the Food Safety Authority (EFSA) and enter into an EU list that allows their market entry as such or for use in food. These specific regulations also lay out label standards for intermediate and end-user sales. Cosmetics-related legislation aims to guarantee high quality and the health and safety of the consumer. It establishes the concept of a Responsible Person to submit all security documentation, safety reports, and safety assessments. Moreover, the Responsible Person must guarantee product traceability and market surveillance. The regulation also specifies label and advertising claims, rules on animal testing, manufacturing standards (GMP), indications relating to carcinogenic, mutagenic and toxic for reproduction (CMR) substances, and nano-materials. Additives for animal nutrition are the most important contents of the related regulation that applies 'only if the additive is authorised according to Regulation (EC) No 1831/2003 and the specific Authorisation Regulation, respecting the conditions set by this rule, can it be placed on the market, used and transformed'. The EFSA is the authority who manages the authorisation under the second principal regulation of interest for the examined products, Regulation (EC) No 429/2008 on "preparation and presentation of applications,

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evaluation, and authorization of additives".

The authors have no conflicts of interest to declare.

The authors thank Dr. Tibor Verduna for his contributions (data research).

Acknowledgements

Conflicts of interest
