The Registration, Evaluation, Authorisation and Restriction of Chemicals (‘REACH’) Regulation (EC) No 1907/2006 came into force on 1 Jun 2007. The central principle of this regulation is to integrate approximately 40 pieces of existing chemical legislations. It has significant influence all over the world. Flavors and Fragrances are widely used in industry, and the manufacture, import and uses of them in EU are regulated under REACH accordingly.

REACH24H Consulting Group has helped hundreds of Flavors and Fragrances enterprises comply with REACH since it came into force. Some of them appointed us as OR to submit the registration acting as the Lead Registrant (LR). With the approaching registration deadline of 2018, more and more Flavors and Fragrances enterprises need to prepare for the registration the sooner the better.

We summarize the previous experience in registration of Flavors and Fragrances to help more enterprises better comply with REACH.

1.   Requirements for Flavors and Fragrances under REACH

As same as other chemicals, the main requirement for Flavors and Fragrances under REACH is registration. The REACH regulation applies to Flavors and Fragrances that are manufactured in the EU or imported into the EU in quantities of  1 ton or more per annum. The enterprise shall submit a registration dossier to ECHA containing the substance identity information and other human health and environment data. For substances that are manufactured in the EU or imported into the EU in quantities of over 10 ton per annum, a Chemical Safety Report (CSR) should also be included. After evaluating the submitted dossier by the registrant, ECHA may request more, such as the submission of more specified hazard information, application for authorization, restriction or prohibition, based on the available data and hazard information.

2.   Particularity of Flavors and Fragrances and Corresponding Compliance Strategies

When complying with REACH, enterprises should consider the raw material, manufacturing process, constituent and properties of the Flavors and Fragrances to take reasonable and scientific strategies.

1)  Judgment of Exemption

Some of the Flavors and Fragrances are from natural sources. According to REACH annex V, “ Substances which occur in nature other than those listed under paragraph 7, if they are not chemically modified, unless they meet the criteria for classification as dangerous according to Regulation (EC) No 1272/200810 or unless they are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII or unless they were identified in accordance with Article 59(1) at least two years previously as substances giving rise to an equivalent level of concern as set out in Article 57(f ), could exempted from REACH registration.” Only fulfill the above requirements, Essences and Fragrances could be exempted from REACH registration. According to Article 3(39), ‘substances which occur in nature’ means ‘a naturally occurring substance as such, unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from air by any means’. According to Article 3(40), a ‘not chemically modified substance’ means ‘a substance whose chemical structure remains unchanged, even if it has undergone a chemical process or treatment, or a physical mineralogical transformation, for instance to remove impurities’.

Then could the natural Flavors and Fragrances be exempted from REACH registration? It depends on the manufacturing process of the Flavors and Fragrances. Actually, most of the Flavors and Fragrances do not meet the definition of ’substances which occur in nature’. Thus, it is necessary to take into consideration both the manufacturing process and the classification of the substance to identify whether the requirements of REACH annex V are well met.

Apart from annex V, there are some other exemption entries that may apply in Flavors and Fragrances. To avoid repeated efforts for compliance with different regulations, substances for certain uses are exempted from REACH registration, such as being used in food or feedingstuffs, medical products. Thus, enterprises should consider whether their substances are used in these products. For example, if a man-made edible flavor is used only in food, then it could be exempted from REACH registration. The Food Safety Regulation already requires that food, feed, for humans cannot be placed on the market unless it is safe, i.e. not harmful to human health and appropriate for human consumption. Moreover, for food additives, food flavorings and their source materials, feedingstuffs additives and animal nutrition, specific pieces of EU legislation already create a system for authorization of substances for those particular uses. Therefore, registration under REACH would be considered as double regulation. However, if there are chemical uses other than food, the chemical used tonnage should be registered. There is no other chemical regulation in EU, thus it should be registered under REACH to indicate that the substance used in chemical industry would not pose risks to human health and the environment or the risk could be controlled.

As the sources and uses of Flavors and Fragrances vary, companies should consider the raw material, manufacturing process, uses and hazards to identify the obligations and exemptions under REACH.

2)     Identification of Product Types

As to the products which deviate from exemptions under REACH, the non-EU potential registrants of flavor and fragrance may need an Only Representative to fulfill relevant obligations, including (pre) registration, communication in the supply chain, authorization and restriction, etc.

These products are common categories of Natural Complex Substances (NCS) of botanical origin. Given this particularity, the registrants should give an unambiguous and correct identification of your substances before registration. First, figure out whether the products are subject to the definition of “substance” or “mixture” under REACH, as mixtures should register each substance within it; when the product is characterized as substance, and then identify it as a UVCB and / or as a mono- or multi-constituent substance. In most cases, flavor products are regarded as multi-constituent substance instead of mono substance for their composition usually contains some isomers with high concentration. It  is important to approach the analytics with full professionalism. Fully justify what you have, analyze properly, get the  full identity package – only then do you really know what you have and can also justify to the authorities what you  have. If you submit the pre-registration with wrong substance type, it may result in being inapplicable for the ‘phase-in’ deadlines.

3)     Obtaining the Registration Data

There are two kinds of registration data you should gather to fulfill the legal requirements for the substances preparing to register under REACH, one is the substance identification and analytical data to prove the registration substance

is same as those placed on the market; the other kind is the assessment data of physicochemical, toxicological and ecotoxicological properties. Especially for the natural flavor products, their chemical compositions vary so widely in complexity that the registrants should keep in mind that good quality data backs up your substance identity and makes inquiring your substance or sharing data for a joint registration more efficient. Whereas if your analytical data is failed

to be that provident, that must be at the cost of registration fees and also make the registration number invalid, and then hinder your future transaction to the EU. For the second kind of data, the registrants can buy the Letter of Access (LOA) directly from LR, if there is a LR. Otherwise, with the absence of LR, you may need help from an external service provider, who can collect data under REACH requirement, including searching for existing data, analyzing exemptions, conducting new tests and using non-testing methods.

Therefore, if you have complex flavor substance or if the LR has not completed the registration, you can always employ

a consultant to give you some guidance to avoid the effects due to lack of experience or professional ability.

3. Available Support from ECHA

If you have pre-registered substances that you manufacture or import from outside the EU above one ton but not more than 100 tons per year and have not yet registered them, the REACH registration deadline of 31 May 2018 concerns you. The following pages on ECHA website help you to understand what you need to do and take you through the process step-by-step for REACH 2018. One of tips has mentioned that you may want to hire a consultant to carry out your REACH-related duties depended on the self-capacity. Further support can be found through the European Federation of Essential Oils (EFEO) and International Fragrance Association (IFRA), on behalf of the entire Essence industry, these associations are obligated to get in close cooperation with ECHA and provide guidelines. In August, the EFEO and IFRA have published guidance for characterizing essential oils. Follow this guidance when you are identifying essential oils for REACH and CLP purposes.

The compliance of the REACH regulation is a prerequisite for entering the EU market for companies of essence and flavor. You must value the significance of your register products and your ability dealing with the Regulations so as to tailor an appropriate compliance package. Take into account the professional consultants who have sufficient background in the practical handling of substances and the information related to them under REACH, in the case that your products concerns the vital benefit of your business which you unable to handle.