Key Regulatory Timeline for Nutrition products/health Products 2019/2020

1. FDA releases Guidances for industry including Q&A for
Publication of Regulation (EU) 2019/2164
implementing new
DGCCRF currently working on new list of authorised
substances in
Reflection on legal framework for use
New additions to annexe III of
Regulation 1925/2008
(Hydroxyanthracene derivatives, Monacoline K, Green tea
catechins, Fennel infusion, Alpha-lipoic acid)
Final discussions and possible vote on draft regulations
setting new limits for
in food supplements, herbs & herbal infusions
KEY REGULATORY TIMELINE
New limit on in food supplements in
several EU countries following health issue in Italy
Ban of foodstuffs containing additive E 171
takes effect
NUTRITION
PRODUCTS
HEALTH
PRODUCTS
Directive 2006/141/EC will be replaced by Regulation
(EU) 2016/127 which sets out requirements for
Regulation (EU) 2018/775 containing rules for indicating
of food takes effect
End of Brexit transition period
Nutrition (Amendment) (EU Exit) Regulations
may take effect in case of 'no deal'
EU Commission holds public consultation period
regarding the impact of labelling additional
(87 vs 26), until Feb 2020
Second Corrigendum: Grace period for some self-
certified Class I medical devices adopted
New limitations on levels of
D4 (INCI: Cyclotetrasiloxane ) & D5 (INCI: Cyclopentasiloxane)
planned to go live March 26th 2020
- Postponed to May 2022
Medical Device Regulations
(MDR 2017/745) will be fully implemented on 26th
May 2020 (end of the 3 year transition period)
Medical Devices / Cosmetic Products
of cosmetic ingredients takes effect
2019
New European Glossary
First notified body accredited under
Medical Device Regulation
Medical Devices Co-ordination Group
(MDCG) releases guidance
for manufacturers of Class I medical devices
revision takes effect
Medical Device Regulation
Organic Food Regulation
ingredient lists & health & safety
recommendations (essential oils, nutrients, botanicals)
EU amends No 1333/2008
on Stabilisers & Use of Ferrous Lactate
FDA releases Guidance for industry with converting
units of measure for several vitamins on
Guidelines published on
applying to products marketed from 1st July 2019 onwards
JUNE
IN PROGRESS
JAN
DGCCRF publishes
Additives Regulation
JULY
curcumin
"Free from" & 'Hypoallergenic" claims
AUG
NOV
Nutrition and Supplement Facts labels
fragrance allergens
DEC
Nutrition and Supplement Facts labels
JAN
Nutrition and Supplement Facts labels
in cosmetic wash-off products
FEB
infant & follow-on formula MARCH
EUDAMED
APRIL
origin of primary ingredient
(titanium dioxide)
MAY
food supplements
cannabis
Pyrrolizidine Alkaloids
DEC
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(Amendment etc)
(EU exit) Regulations may take effect in case of 'no deal'
End of Brexit transition period
Product Safety & Metrology etc (Amendment etc) (EU Exit)
Regulations may take effect in the case of ‘no deal’
Medical Device Regulation
2nd Omnibus regulation ((EU) 2019/1966)
takes effect
MAY
(Regulation (EU) 2019/831)
published, adding CMR substances to the annexes of
Cosmetic Regulation.
Omnibus Regulation
2020
© 13.02.20. RNI Consulting. All rights reserved.
© 13.02.20. RNI Consulting. All rights reserved.