Nice, France, 4 th June, 2018 E.F.E.O. European Federation of Essential Oils. Legislation update

Transcription

1 Nice, France, 4 th June, 2018 E.F.E.O. European Federation of Essential Oils Legislation update Current EU legislation and legal developments relating to Essential Oils 2017/2018 Lutz Düshop Attorney at law Secretary General to E.F.E.O

2 Legislation concerning Essential Oils Foreign Trade & customs Regulations Biocide products Regulation No 528/2012 REACH & CLP Nagoya protocol CITES Regulation No 338/97 Flavourings Regulation No 1334/ 2008 Cosmetics Regulation No 1223/2009 Med. products Directive No 2001/83 & GMP/GDP Feed Additive Regulation No 1831/2003 Contaminants Regulation No 1881/2006

3 REACH, before and after 31st May 2018 REACH Registration Regulation (EC) 1907/2006 the major challenge since more than 10 years temporarily finished on 31th May 2018 After 01 st June 2018: The nightmare has not ended!

4 REACH in brief REACH (1)

5 REACH in brief REACH (2)

6 REACH and CLP REACH(3)

7 REACH(4) last aid from ECHA ECHA last minute solutions: DCG Directors Contact Group 1. Incomplete dossier ( data not available) 2. Legal entity change (unforeseen mergers/splits) 3. Lead registrant failing his submission (one of the member registrants to take over) 4. Substance with no registration intention (downstream user to take importer s role if e.g. OR fails to register)

8 REACH Statistics

9 REACH Statistics Top Ten (1)

10 REACH Statistics Top Ten (2)

11 REACH (5) Since 01st June 2018 : What happens if no registration dossier has been submitted for pre-registered substances? No EU imports of essential oils for cosmetic purposes No use of such essential oils by customer Imports suspended until registration dossier has been submitted Goods on stocks may be sold as they are regarded imported (= physically introduced into EU customs territory )

12 REACH (6) European Court jurisdiction on REACH-exports C - 535/15, April 2017 Clarification of REACH Definition Judgement the export of a substance to a third country cannot be considered as the placing on the market of that substance within the meaning of Article 3(12) and Article 5 of the REACH Regulation Possible cases of practical use? Export of n.r. substances produced/imported in the EU before 31 May 2018? Export of n.r. substances rededicated for use in REACH related applications?

13 REACH (8a) A look into the future: What will happen next? ECHA News Letter release No 2/17 th May 2018: SME Status will be checked At least 5% of the dossiers will be checked for compliance Substance evaluation: further information requests from ECHA EU-wide enforcement project on REACH registration in 2019

14 REACH (8b) Post- registration -period: Companies need to keep their registration dossiers updated - ECHA REACH Roadmap 2018 phase 7

15 REACH (8c) Post- registration -period: ECHA recommendations

16 REACH (9) Safety Data sheet annex II of Regulation 1907/2006 Don t forget: As of 1st June 2018, REACH registration number to be mentioned under section product identifier!

17 REACH (10a) Further effects of REACH: ECHA Candidate list of substances of concern (currently 181 entries) Possible consequences: Regulation (EC)1907/2006, annex XIV - list of substances subject to authorization Regulation (EC) , annex XVII -list of restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles

18 REACH (10b) Regulation (EC)1907/2006, annex XIV - list of (>30) substances subject to authorization Regulation (EC) , annex XVII -list of restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles (> 67 entries) Amendments on several CMR substances as from 01 st December 2018

19 CLP Regulation since 2010 CLP Regulation (EC) No 1272/2008 on classification, labelling, packaging Application: 1st December 2010 (substances) and 1st June 2015 (mixtures) Pictograms, Hazard statements, Precautionary statements

20 CLP amendments (1) Amendments by Regulation (EU)2017/776: Annex VI (Harmonized classifications), amendments applying from 01 st December 2018 Harmonized ATE = Acute Toxicity Estimates for the classification of mixtures Deletion of references to Directives 67/548/EEC and 1999/45/EC by 01 st June 2017 (relabeling date for mixtures placed on the market before 01 st June 2015) 24 new entries of substances ( i.a. linalool and coriandrol): Skin Sens 1B H317 GHS 07 Wng

21 CLP amendments (2)- Art.45 Amendments by Regulation (EU)2017/542 as of 1 st Jan New annex VIII parts A, B, C (information on mixtures) Purpose: Information to be provided to poison centers and appointed bodies in the EU MS. Applies to importers and downstream users ( not addressed: producers) Annex VIII part C : submission format identification of the mixture and of the submitter; classification of the mixture, label elements and toxicology; product identifiers of the mixture components. Application depending on end users: 2020 (fin. consumer) / 2021 (commercial use) /2024 (industrial use in sites)

22 ECHA Guidance Paper CLP amendments (2)- Art.45

23 CLP amendments (3) Most recent amendment by Regulation (EU) 2018/669 published in OJ of 04 th May 2018 annex VI -List of substances under harmonized EU classification effective as of 01st December 2019 Check your portfolio! Not yet reflected in annex IV: Re-classification of d-limonene Currently : H 400, H 410 ECHA CLH Report : H 400, H 412 Procedure still going on

24 Cosmetics Regulation 1223/2009 since 2013

25 Cosmetics Regulation 1223/2009 since 2013 Still pending: fragrance allergens Last major change : Regulation (EU) 2017/1410: Ban on HICC, Atranol and Chloroatranol ex oak tree moss as from 23rd August 2019

26 Flavouring Regulation 1334/2008 (1) Aromatic extracts- no authorization required Chemically defined flavouring substances authorized and listed in the Unions list

27 Flavouring Regulation 1334/2008 (2)

28 Flavouring Regulation 1334/2008 (3) Several changes on the Community list annex I : Chemically defined flavouring substances, following EFSA Flavouring group evaluations Regulation (EU) 2017/378 (20 substances, use restrictions) Regulation (EU) 2017/378 (deletion) 4,5-epoxydec-2(trans)-enal Regulation (EU) 2018/678 (addition of 9 substances) May 2018

29 Essential oils used for medicinal purposes (1) Essential oils from field distillation: GACP Processed/rectified/purified essential oil: EU Directive 2001/83/EC, GMP, written confirmation (1 st July 2013), GDP (21 st September 2015)

30 Essential oils used for medicinal purposes (2) Essential oils from field distillation: GACP Processed/rectified/purified essential oil: EU Directive 2001/83/EC, GMP, written confirmation (1 st July 2013), GDP (21 st September 2015)

31 Essential oils used for medicinal purposes(3) Good Distribution Practice also for essential oils required

32 Essential oils as feed additives(1)

33 Essential oils as feed additives (2) EFEO support activities

34 Pesticides Regulation No 396/2005 (1) MRL ( Maximum Residue Limits) MRLs refer to the listed plant source material MRL applicable to essential oils from the source material! Compliance of the source material = compliance of the E.O. Calculation: concentration factor based on experience General Rule: 0,01 mg/kg for non-listed pesticides! Frequent updates: appr. 130 Regulations since 2006 Public awareness (authorities, customers, consumers)

35 Pesticides Regulation No 396/2005 (2) No processing factors/concentration factors determined by Regulation 396/2005: Art. 20 (1)- changes caused by processing to be taken into account Art. 20 (2) and annex VI no specific factors set. Current considerations on EFSA level: Calculation of processing factors Context: authorization procedure for plant protection substances Not designed as factors under Regulation 396/2005!

36 Contaminants Regulation (1) Regulation 1881/2006

37 Contaminants Regulation (2) Regulation (EC) 1881/2006- future amendments? EU Commission considerations : New maximum levels for OTA

38 Contaminants Regulation - PAH (2) Amendment: Maximum levels for Polycyclic aromatic hydrocarbons (PAH) since 1 st April, 2016

39 Contaminants - specific import rules (3) Import conditions for capsicum and nutmeg (aflatoxin load) as from 2 nd February 2016 Capsicum sp. & nutmeg from India Nutmeg from Indonesia Affected: dried source material (annex) and products derived (extracted) from dried material Requirements: Sampling and analysis Health certificate (EU specimen)

40 Other contaminants PA A new challenge since 2013: PA -pyrrolizidine alkaloids from weeds affected: different herbal infusion materials might PA also be present in essential oils extracted from plant source material? only a German problem?- Not at all!

41 Biocidal products Regulation (EU) 528/2012 (Article 95) Since 1 st September 2015: Biocidal products need authorized active substance suppliers Supply chain: trade by non- authorized companies?

42 CITES and EU Regulation No 338/97

43 New Novel Food Regulation Essential oils and extracts e.g. as food supplements? New NF-Regulation (EU) 2015/2283, ex (EC) 258/97 ( 01 st January 2018) Authorization procedure for products not consumed as food in the EU before 1997 Change of system: Products on the Union list may be marketed also by nonapplicants Simplified authorization procedure for plant materials used as traditional foods in Third countries with a safe history of use (25 years) Implementation Regulations (19 th January 2018) : (EU) 2017/2469 on administrative & scientific requirements (EU) 2017/2468 on administrative & scientific requirements for traditional food from Third countries (EU) 2017/2470 Union list of Novel Foods

44 New Novel Food Regulation Implementation Regulation : Union list

45 Nagoya Protocol Regulation No 511/2014 EU as per October 2015 Impact on essential oils? - Background: Access to genetic resources and benefit sharing - Material concerned: Genetic resources = i.a. material of plant or other origin containing functional units of heredity of actual or potential value (also essential oils!) - Obligations for Users = companies conducting research and development on the. composition of genetic resources, utilizing resources or traditional knowledge associated with genetic resources - Not addressed: import traders, no obligation for trade EU - EU Guidelines 2016/C 313, Aug Aspects of reality/practice? questionnaires, confirmations etc.

46 Current Trade Issues : Regulation (EU)2018/724 EU additional customs duties on goods from US - possible reaction: 1 st step: 20 th June 2018 up to 25% annex I Cosmetic beauty products/preparations 2 nd step: 23 rd March 2021 up to 10% annex II Orange oil, not deterpenated Lemon oil, not deterpenated Other (terpenic byproducts, extracted oleoresins)

47 Nice, France, 04th June 2018 E.F.E.O. European Federation of Essential Oils Legislation update 2017/2018