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E.F.E.O. FAQ collection

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The following compilation of responses to selected questions received from members in 2016/2017/2018 is deemed to be of general interest and thus made available to the members as an information source. The FAQ collection is grouped by thematic areas and will be regularly amended and extended by further topics.

Please accept:
The answers solely reflect the legal opinion of the author at the E.F.E.O. Secretariat and are issued without assuming any responsibility for the correctness, completeness and actuality of the content concerned. Neither the author nor E.F.E.O.´s Board or E.F.E.O. as such may be held liable. 

Companies should also make use of other information sources and seek for legal advice and consultancy on their own responsibility.

I. REACH,SDS & Chemicals legislation

2. Do contract clauses/INCOTERMS have any influence on our obligations under REACH, and may registration be avoided by choosing the most adequate clause or INCOTERMS?

The INCOTERM clauses may be one of the tools to identify the importer in the meaning of REACH, particularly as such clauses determine the contract partner responsible for physically introducing the substance into the EU territory (e.g. in case of purchases/ imports under EXW, FCA, FAS, FOB). This is also reflected in the ECHA Guidelines on Registration (version 3.0 Nov. 2016, explaining that “In case of import the registration should be made by the legal entity established in the EU who is responsible for the import. The responsibility for import depends on many factors such as who orders, who pays, who is dealing with the customs formalities or the INCOTERMS chosen, but this might not be conclusive on its own”.

II. CLP – Classification, labelling, packaging

1. Are there any rules on labelling/information requirements for Essential Oils if only sold for export to non-EU countries?

Yes, indeed.
Please see Regulation (EU) No 649/2012 on the import and export of hazardous chemicals. The export rule (Art. 17) applies to all chemicals in general if intended for export. Exported substances including Essential Oils must be packaged and labelled as provided for in the “CLP”- Regulation No 1272/2008 and be accompanied by a Safety Data Sheet complying with REACH-Regulation 1907/2006. The language rules on labelling and SDS seem to be less severe than those applied within the Union market: In the export case, label information and SDS shall be given in the official language of the country of destiny, “as far as practicable”.

III. EU Cosmetics Regulation

4. Is there any binding compendium of substances used for cosmetic purposes, with might enable us to correctly label the Essential Oils supplied to the cosmetic industries?

Yes indeed.
The so-called INCI (inventory and common nomenclature of ingredients in cosmetic products) set up by the EU Commission allows to identify the correct names of many substances (including Essential Oils and extracts) in the way they need to be declared on the finished cosmetic product label.

IV. EU Flavourings Regulation

V. Essential Oils for feed additive application

VI. Medicinal legislation

2. Which rules do apply in case of pharmaceutical Essential Oils derived from simple field distillation (i.e. not further processed in the country of origin)?

Essential Oils derived from a simple initial distillation process (“field distillation”), carried out directly after the harvest in the country of origin, are regarded subject of Good Agricultural and Collection Practice (GACP) rather than GMP part II for active pharmaceutical ingredients. This is also reflected in GMP annex 7 (manufacture of herbal medicinal products):
“Regarding the expression from plants and distillation, if it is necessary for these activities to be an integral part of harvesting to maintain the quality of the product within the approved specifications, it is acceptable that they are performed in the field, provided that the cultivation is in compliance with GACP. These circumstances should be regarded as exceptional and justified in the relevant marketing authorization/registration documentation”. Thus, in these cases, for importation into the Union a “Written confirmation” is not required.

VII. Pesticides and Contaminants in Essential Oils/extracts for food use

2. Is there any general or product-specific processing or concentration factor provided by the legislation, or any official EU Guideline relating to this issue?

Currently, Regulation 396/2005/EC does not provide any processing factors/concentration factors applying to products processed from the source materials covered by this Regulation.
Annex V to the Regulation is still void. Thus, companies have to identify adequate product specific processing/concentration factors in their own responsibility. Regularly such factors will be based on the ratio of the raw material quantity used, to the quantity of the product resulting from the process. In practice: If the raw material is compliant with the MRL set by the EU Pesticide Regulation the Essential Oil/extract derived from it will be compliant as well. This provided, the residue quantity (mg/kg) detected in the Essential Oil divided by the processing factor will result in a calculated value (mg/kg) for the plant raw material. If not exceeding the MRL set for this specific source material, the Essential Oil or extract may be regarded compliant and may be placed on the market for application in the food sector. It should be noted that currently there are some first ideas on the national level (German Institute for Risk Evaluation BfR) targeting at a scientifically- based approach on the calculation of processing factors for herbal materials which might also affect Essential Oils.

VIII. EU Biocides Regulation

1. We intend to import an Essential Oil for use in a biocidal product. Is this possible without restrictions, or do active biocidal substance need to be authorized?

Under the Biocidal Products Regulation (EC) No 528/2012 (“BPR”), replacing the former Directive (98/8/EC), active biocidal substances may only be used in biocide products if authorized by the EU , following an evaluation procedure carried out by the European Chemicals Agency , see ECHA webpage, chapter on BPA. For some substances used for biocidal purposes (Article 25a and Annex I), a simplified procedure has been installed, i.a. concerning Lavender oil and Peppermint oil. Authorized substances are listed in a Union list, see list of approved substances available on the ECHA homepage.

IX. EU foreign trade Regulations

X. EU Customs tariff Regulations, preferential/non-preferential origin, suspensions

XI. US-FDA and other non-EU legislation

2. Our US customer demands us to declare whether or not our product is on a “list of active substances”. What is the background of this question?

The question refers to the TSCA as amended by the “Lautenberg Chemical Safety for the 21st Century” Act. The (interim) Active Substance list is about substances to be reported under this legislation which have been prioritized for risk evaluation. Substances exempted from reporting are on the Exempt Substances list . In both cases, some Essential Oils are listed.

XII. Other subjects (i.a. Nagoya, CITES, specific uses)

2. Is there any information/expertise available that might help us to understand the requirements in relation to the Nagoya protocol?

The EU-Commission (see publication in OJ C 313 of 27th August, 2016) has issued a Guidance document on the scope of application and the core obligations of users, i.a. describing some obligations on users under consideration of “due diligence” (which i.a. means to clarify the access conditions, identify the need of access permits, to conclude contractual agreements with relevant parties in the countries of origin etc.). Possible effects on (import) trade in Essential Oils, if any, are clarified under the Guideline section “Genetic resources as traded commodities”, saying that “Trade and exchange of genetic resources as commodities (such as agricultural, fisheries or forestry products — whether for direct consumption or as ingredients, e.g. in food and drink products) fall outside the scope of the Regulation. The Protocol does not regulate issues related to trade, but is applicable only to utilisation of genetic resources. As long as there is no research and development on genetic resources … the … Regulation does not apply“.

LD/SFR 2nd March, 2018 fin


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