G/TBT/W/629  
 
8 April  2019 
(19-2241) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
ISRAEL - ADDENDUM TO  THE PHARMACIST REGU LATIONS (COSMETICS 5 778-2018)  
STATEMENT BY THE EUROPEAN UNION TO THE COMMITTEE ON TECHNICAL BARRIERS T O TRADE  
6 AND 7  MARCH  2019 
The following communication, dated 5 April  2019, is being circulated at the request of the delegation 
of the European Union .  
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1.  The European Union (EU) would like to thank the Israeli authorities for providing the opportunity 
to comment on the "Addendum to the Pharmacist Regulations (Cosm etics 5778 -2018)", notified as 
G/TBT/N/ISR/709/Add.2 on 23 January 2018, and would like to thank Israel for its reply to these 
comments received on 24 February 2019. The EU welcomes Israel 's declaration to examine all the 
comments submitted with regard to the formulation of the Regulations in the process of re -
examining the text of the Regulations.  
2.  In August 2017, the EU provided comments on the "Addendum to the Pharmacist Regulations 
(Cosmetics) 5777 -2017", notified as G/TBT/N/ISR/709/Add.1. Following the  assessment of the 
newly notified Addendum 2, the EU would like to express its concern that our comments on important 
issues submitted to Israel in August 2017 have not been taken into account. Therefore, the EU would 
like to call on Israeli authorities to  provide replies to EU 's concerns expressed also in in August 2017.  
3.  The EU welcomes the Israeli initiative to move towards harmonisation with Regulation 
(EC) No. 1223/2009 ("Cosmetics Regulation "), in particular the move from a pre -market control 
system to  a post -market control system.  
4.  Given that the two above -mentioned sets of EU comments concerned many technical issues, the 
EU will recall only the most important issues of the notification G/TBT/N/ISR/709/Add.2.  
5.  The new Pharmacists Regulations will  require the Responsible Person to submit quarterly reports 
for every product which is not in line with the EU Cosmetics Regulation. The EU is concerned that 
this requirement would be very challenging and time consuming for companies without providing 
additional  protection to consumers. The EU would therefore like to recommend to Israeli authorities 
to reconsider this new obligation.  
6.  The EU would like to propose to remove or make optional the requirement to provide a barcode 
number according to the cosmetic produ ct's packaging.  
7.  Concerning the requirement for Good Manufacturing Practice (GMP) certification from an 
authority, the EU would like to stress that it is not in line with the EU Cosmetics Regulation or with 
any international practice across the world. A cl ear disadvantage is already being observed for 
companies based in those EU countries which do not have a competent authority delivering GMP 
certificates.  
8.  The EU would like to ask Israel for clarifications on the enforcement of the rules for parallel 
impor ters foreseen in the draft measure and what options, if any, main importers will have to seek 
redress if the rules are not followed.  G/TBT/W/629  
 
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  9.  The draft Israeli Regulation requires notifying products containing nanomaterials six months prior 
to placing on the market . In the EU, such requirements do not apply to nanomaterials already listed 
in Annexes III to VI of the EU Cosmetics Regulation. The inclusion of nanomaterials in the EU 
Annexes means that they have undergone very extensive risk assessment and have a favou rable 
opinion (in their nano form) from the EU Scientific Committee for Consumer Safety (SCCS). The EU 
strongly recommends following this approach where the pre -notification process applies only for new 
nanomaterials that are not yet listed in any Annex of  the EU Cosmetics Regulation.  
10.  The EU would like to underline the fact that a sufficient lead time is needed to ensure the proper 
functioning of the new regulatory system. The EU would like to recommend a transition period of at 
least one year to implement  the new legislation and at least six months after the notification portal 
is fully functional, to ensure that companies comply with the new requirements and that blockages 
are avoided at the borders. It is important to note that when the notification syst em was introduced 
in Europe in 2013, it entered into force after a 3.5 years transition time (the EU Cosmetics Regulation 
was published in 2009).  
11.  in the past few years the EU  has been actively engaged with the Israeli authorities through 
sharing our best practices and we are ready to continue with this engagement if the Israeli side 
thinks it helps the process.  
12.  The EU would like to ask once more Israel to take the above comments into account, and to 
provide replies to the issues previously raised and not y et replied to.  
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