COP 2008

EFFA-CODE OF PRACTICE 2009 FOR THE HAZARD CLASSIFICATION AND LABELLING AND FOR TRANSPORT OF FLAVOUR AND FRAGRANCE SUBSTANCES AND PREPARATIONS (MIXTURES) ACCORDING TO THE EU-REGULATIONS

Within the European Union substances and preparations have to be classified and, if dangerous according to criteria laid down in the regulations, have to be labelled according to certain rules. The classification and labelling of substances is either prescribed in Annex I (now being repealed and transferred into Annex VI of CLP, see below) to the Dangerous Substances Directive 67/548/EEC (DSD), or has to be done by the supplier using the criteria of Annex VI of this Directive. For preparations, like flavour and fragrance compounds, it must be done according to the Dangerous Preparations Directive 1999/45/EC (DPD).

CLP:
On 20 January 2009 Regulation (EC) 1272/2008 (the so-called CLP Regulation) entered into force, which is going to substitute the existing DSD and DPD. The latter Directives are going to be repealed with effect from 1 June 2015. Until then a transition period has been granted in which both hazard classification and - communication systems co-exist.
This CLP introduces the requirements of the UN Globally Harmonised System of classification and labelling of chemicals (GHS) into EU law. In accordance with the building block principle of the GHS not all hazard classes are taken up by the EU, only those that were present in the DSD system.

Implementation of CLP with transitional provisions:

According to Article 61 a staggered approach with deadlines of 1 December 2010 (for Substances) and 1 June 2015 (for Mixtures) has been granted:

Dec 2010: EU GHS(CLP) for Labelling & Packaging;
DSD and EU GHS(CLP) for Classification

                                                      Mixtures:          until 1 June 2015:         DPD for Classification&Labelling&Packaging
after 1 June 2015:        EU GHS(CLP) for Classification&Labelling
                      &Packaging

Also a transition period of 24 months is provided for relabelling and repackaging - if substances and mixtures are on the market before 1 Dec 2010 (Substances) and 1 June 2015 (Mixtures).

GHS(CLP) Classification, Labelling and Packaging for Substances & Mixtures can be applied immediately, before the above mentioned deadlines, however the Classifications of DSD and DPD have to be kept for the hazard communication.

Suppliers are free to use either of those options during the transitional period.

Hazard Assessments:
The substances covered by this EFFA Code of Practice (Code) are scrutinised by following the

· UN Globally Harmonised System of classification and labelling of chemicals (GHS Second Revised Edition)

Entries are listed in the attachments of the IFRA/IOFI Labelling Manual (LM) which serves as a master reference of the fragrance and flavour industry covering regional needs.

Several substances of interest to the fragrance and flavour industry are officially classified in the EU and have been mentioned in Annex I of the DSD. Note that this Annex I has been repealed and officially classified substances are now published by tables 3.1 and 3.2, respectively, of Annex VI of the CLP.
Those substances - including the entries of the 30^th (Com. Dir. 2008/58/EC) and of the 31^st and last ATP (Com. Dir. 2009/2/EC) to the DSD - are listed in the respective attachments of the LM with their Index number next to their CAS and EU number. Any information assigned to a substance, both for classification and labelling, obligatorily has to be used in the Member States of the European Union and the label must carry the word “EU label”. The EU-number, which is either the EINECS or ELINCS number, has always to be mentioned on the label.

This Code of Practice for hazard classification and labelling is not to be considered as an exhaustive list of substances, but is intended to deal with substances of interest to the flavour and fragrance industry. A substance not listed in this LM but used in flavour and fragrance industry cannot be considered as not classified. It is the responsibility of the user to consult physico-chemical and toxicological data and decide whether a classification and a label are necessary. Companies who use such substances not listed in this LM are kindly asked/recommended to inform the EFFA secretariat about this use and about their decision/proposal for classification and labelling.

The DSD and its amendments are implemented in the legislation of the EU’s Member States and, with some national deviations in the associated EFTA countries. This Code follows the EU’s Directives. However, any national deviations from the EU Directives should be taken into account. Switzerland is following the same GHS approach as lined out by the CLP regulation. Moreover, Switzerland accepts GHS labelling since publication of the latest update of the Chemicals Ordinance effective on 1 February 2009.

The CLP, being a Regulation, does not allow national deviations as it is directly applicable in all EU Member States.

An IFRA/IOFI GHS Task Force of the global flavour and fragrance industry with representation from Europe and other regions has discussed the classification and labelling of substances of interest to the flavour and fragrance industry. This Task Force has taken into account the toxicological and eco-toxicological data available for these substances at the time of the publication of this Code. Those that are to be classified as hazardous are included in the attachments of the IFRA/IOFI LM as well as those which are not classifiable based on current knowledge.

The information provided in this Code is intended to provide directions to companies doing business in Europe to assure a consistent hazard classification and labelling for fragrances and flavours and their ingredients.

CLP classifications fully covered by UN GHS classifications of the LM
The UN GHS classifications released by the IFRA/IOFI LM are applicable for the EU under CLP except for the following hazard classes / hazard categories which are not implemented in the EU and can therefore simply be dropped for EU purposes:

Note that the European system on hazard classification and communication (Safety Data Sheets and Labels) covers a number of hazards that are not (yet) addressed in the GHS, these are kept in the CLP (see art 25 and its Annex II, part 1and 2) as supplemental hazard information (according to GHS 1.4.6.3 and 1.4.10.5.4.2). Not many of these hazards are of interest to Flavour and Fragrance ingredients, the most important ones are probably

- ‘dryness or cracking of skin’, i.e. materials assigned R66 (Repeated exposure may cause skin dryness or cracking) which under the CLP is retained as hazard statement EUH066 (Annex II, 1.2,4) and

- the requirement for mixtures not classified for skin sensitization but containing more than 0.1% of at least one sensitising substance to bear ‘Contains …(name of sensitising substance). May produce an allergic reaction’ (EUH208) on the label(Annex II, 2.8).

· The attachments of the IFRA/IOFI LM are not comprehensive and the absence of a substance or a specific classification should not be taken as implying that no labelling is required.

· In order to make the Attachments as comprehensive as possible, the IFRA/IOFI GHS Task Force welcomes for consideration any proposal for additions on the basis of the voluntary shared knowledge within the Flavour and Fragrance Industry.

· The substances examined by the Task Force, i.e. those without Index numbers, have been considered for their flammability. Results using the Pensky Martin Closed Cup (PMCC) method were taken as the reference. Due to the variability of flash point determinations (e.g. influenced by minor impurities and variations in the compositions of oils), values of flash points are the responsibility of the member companies; they should not rely on the recommendation as contained in the Code, but be responsible for their own data.

· The listing of a substance in one of the attachments of the IFRA/IOFI LM does not mean an approval for use in flavours or fragrances. Indeed some of the substances may be subject to restrictions for specific applications, such as the IFRA Standards, EU Cosmetic Legislation, flavour regulations, etc.

· The implementation of a new or an amended classification or labelling should be initiated after publication of the updated Code (see section G).

· To some of the substances individual limit concentrations have been assigned in tables 3.1 and 3.2 of Annex VI of CLP. They are mentioned in the attachments of the IFRA/IOFI LM and have to be followed instead of the general so-called administrative limit concentrations when classifying a mixture (preparation) according to the conventional method of the DPD and the additivity rules of CLP respectively .

Each supplier is reminded that he bears the final responsibility for the appropriate classification and labelling of the products he puts on the market in the EU.

Members should be aware of and fulfil all their obligations under applicable national and European laws and regulations. The guidance given by EFFA does not relieve members of their obligations under those laws and regulations and members should always satisfy themselves in any particular instance that the suggestions made by EFFA can be properly followed. EFFA nor any individual members or officers, can be held liable for any loss or damage suffered by any member or by any person as a result of following or relying on the EFFA Guide or other EFFA documentary materials.

Although the Code of Practice has been carefully prepared by our services, EFFA can not be held liable for errors or omissions in this document. The guidelines or recommendations given by EFFA should not be considered or used as a substitute for legal advice.

EFFA nor any individual members or office, can be held liable for any loss or damage suffered by any member or by any person as a result of following or relying on the EFFA Code of Practice or other documentary materials.

By using this Code of Practice, you will be deemed to understand and accept the conditions of this disclaimer.

Some substances and preparations pose a specific hazard upon ingestion: they can reach the lungs and cause lung damage. The criteria for classification are purely of a physico-chemical nature (ref. 25^th Adaptation, Directive 98/98/EC of 15-12-1998):

Substances and preparations falling within these criteria need not be classified if their surface tension is over 33 mN/m at 25°C. Only indicative classifications are given in the attachments because different qualities may have different properties in regard to the above criteria.

Based on measurement results for a number of Natural Complex Substances (NCS) with hydrocarbon contents between 10 and 90+ % and on similar measurements of some flavour and fragrance compounds, the Task Force has come to the conclusion that in practice substances and preparations containing more than 10% of hydrocarbon(s) fall within the criteria for viscosity and surface tension, unless the material is solid or reported to be a viscous liquid (kinematic vicosity considered to be over 7 x 10(-6) m²/sec at 40°C). It should be noted that the hydrocarbon contents that are mentioned in Attachment II are maximum values to avoid underclassification when NCSs are used in fragrance or flavour compounds.

- to determine the hydrocarbon content of substances (supplier information, analysis) and preparations (calculation) and to classify as Xn; R65 if more than 10% is present;

- that non-classification should only be possible if viscosity and/or surface tension measurement results are available for a specific, not obviously viscous substance or preparation.

Skin sensitizers are labelled Xi, R43. It is recommended to use the administrative limit concentration of 1 % when classifying preparations containing them in all cases, unless a different threshold is laid down in Annex VI of the CLP.

D. Classification of Natural Complex Substances (NCS)

Natural complex substances (NCS, e.g. essential oils, extracts from botanical and animal sources) require special procedures due to the fact that they might have quite different chemical compositions (and therefore hazard classifications) under the same designation. This may occur even when this differentiates between species, cultivars and chemotypes and different production procedures [e.g. absolutes, resinoids, distilled oils].

A NCS may be classified on the basis of the data obtained by testing the NCS. The test results of a NCS, even if containing classified constituents, are evaluated in accordance with the DSD. The health and environmental hazard classification derived following this approach are quality dependent and therefore are indicated in the “NCS” section, Attachment V of this Code in brackets, because uncertainty may exist over whether any particular quality of a NCS corresponds to the quality on which the tests and measurements were carried out.

For grades of NCSs and for endpoints for which reliable test data are lacking the EU’s Labelling Guide (Annex VI to the DSD; Annex I of the CLP) incorporates a requirement introduced by Commission Directive 93/21/EEC, whereby the hazard classification of complex substances shall be evaluated on the basis of levels of their known chemical constituents. Where knowledge about constituents exists, e.g. on substances limited as per Annex II of Dir. 88/388/EC or on substances with sensitizing, toxic, harmful, corrosive, environmentally hazardous properties, the classification and labelling of these NCSs according to the requirements of the European Union should follow the rules for preparations (= mixtures) as prescribed by the DPD.

The resulting classification and labeling using this approach is given in Attachment V in brackets (due to the inherent uncertainties both in test- and compositional data, see above), a guidance for the abundance of the hazardous substances occurring in the NCSs considered is provided in Attachment III which is a result of the shared knowledge of the Industry at the time of the publication of this Code.

It should be noted that the current Attachment V assigns the status “not finally validated” to those NCSs which at the time of release of this Code were not yet finally approved.

Because isolation and purification processes can have a significant influence on the composition of NCSs, users of this Code are further reminded that the classification and labelling of a particular quality of a NCS should be based on the actual levels of classifiable substances in that quality which might differ from the ones used to arrive at the conclusions in Attachment V. This is an additional reason why the recommended classification and labeling of Attachment V of this Code are put in brackets.

NCSs that do not require Classification and Labelling, based on the current shared knowledge, are integrated in Attachment V of this Code.

E. CLASSIFICATION OF FLAVOUR AND FRAGRANCE COMPOUNDS CONTAINING NATURAL COMPLEX SUBSTANCES

Flavour and Fragrance compounds are preparations in the sense of the EU Directive 67/548/EEC. They should be classified and labelled according to the EU’s DPD 1999/45/EC and its articles 6 and 7.

In practice test data on the flavour or fragrance compounds are not available or collected. Therefore the classification of these products should be based on the chemical composition and should include the contributions of hazardous substances present as constituents in the NCSs present in the formulation.

This Code of Practice adopts this as the general principle for flavour and fragrance compounds.

This implies that the hazardous substances present in a NCS should be known and it is recommended to request that this information be included in the Safety Data Sheet (section 3) according to REACH Regulation (EC) 1907/2006 replacing Commission Directive 91/155/EEC) of the NCS. In case of absence of this information the Attachment VI can be used.

However, it should be realised that when a NCS is mentioned in Annex VI of CLP (formerly ANNEX I of the DSD) [Turpentine oil is the most important example] this classification must be used and not the classification resulting from the constituents. Likewise, for endpoints where the NCS classification is based on test data, this classification overrides the classification resulting from constituents for that endpoint (in Attachment V indicated with footnote 3a-c).

F. TRANSPORT CLASSIFICATION

The assignment of UN numbers, packing group and hazard class is based on the criteria as laid down in the Recommendations on the Transport of Dangerous Goods Model regulations as published by the United Nations, 14^th edition (so-called Orange Book). The assigned UN-number is a recommendation, which should be used to verify detailed differences between the various modes of transport, such as: air, sea and land (land transport can be separated into road, rail and in-land water ways).

Where needed, the EU hazard classification of the substance is supplemented with the ADR-rules, including the links to the EU-DSD and DPD.[1]

Also, for transport, due account should be given to any national deviations from the rules applied here.

The time for implementing new or modified classifications, as indicated in Attachments with EU relevance, i.e. Attachments I, III, IV (Chemicals) and V (Natural Complex Substances) of the IFRA/IOFI LM and as approved by the Task Force, should not exceed a period of six months following the publication of the amended Code of Practice.
Regarding the CLP classifications it is up to the individual companies to decide at what time they wish to apply CLP (see section A.); however it should be noted that as from 1 December 2010 substances have to be labelled and packaged according to CLP and both DSD and CLP classifications have to be used
Please note further that the legal requirements regarding compliance dates of any new officially classified substances, i.e. those bearing an EU Index number, prevail over the above mentioned six months period as agreed on by our industry.

Please note that this table includes substances which have been identified by the Task Force of having L(E)C₅₀ values of less than or equal to 0.1mg/l and larger than 0.01mg/l for acute aquatic toxicity. Following UN GHS for these substances M-factors of 10 have been assigned.

Please note that this table includes substances which have been identified by the Task Force of having L(E)C₅₀ values of less than or equal to 0.1mg/l and larger than 0.01mg/l for acute aquatic toxicity. Following Directive 2006/8/EC for these substances specific concentration limits are applied.

Table of UN GHS, UN TDG, EU DSD and US OSHA hazard classifications/hazard statements for Natural Complex Substances (NCS).

As outlined in section D. the annotation “not finally validated” has been assigned to those NCS which at the time of release of this IFRA-IOFI Labelling Manual were not yet finally approved.
All entries are not finally validated and placed in brackets:
Please be reminded that classification and labelling of a particular quality of a NCS should be based on the actual levels of hazardous substances in that quality which may differ from the ones used to arrive at the conclusions in this attachment.

Table on the potential presence of hazardous substances in natural complex substances (NCS) containing percentage information, UN GHS and EU DSD classification.

As explained in sections D. and E. in the case of absence of information about actual levels of hazardous substances present in natural complex substances this list should be taken into account for the hazard classification of NCS and for their contributions to the hazard classification of flavour and fragrance compounds.

[1] In certain cases, the following choices have been made:

a) Multifunctional substances:

Preference is given to the general UN-number (e.g. 2-Methyltetrahydrofuran-3-one is classified as a flammable liquid UN1993 and not as an ether UN3271 nor a ketone UN1224).

b) Stench:

IATA – Transportation hazard class UN3334 and UN3335 are available for substances which are not classified according to other classes but are considered “NOXIOUS” (R67 or reported personal experience).

c) class 3

UN 1169, Extracts, aromatic, liquid has been selected to be used for the flammable naturals (essential oils) as the best fitting generic UN number.

d) UN number in between brackets.

UN numbers of substances which have flashpoints close to the limits of the criteria are given in brackets. The assigned UN number should therefore be checked against the actual flashpoint of the batch.