G/TBT/W/573  
 
29 November 2018  
(18-7556) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
 
ISRAEL — ADDENDU M TO THE PHARMACIST REGULATIONS  
(COSMETICS 5778 -2018 ) 
STATEMENT BY THE EUR OPEAN UNION TO THE COMMITTEE ON TECHNICAL BARRIERS T O TRADE  
14 AND 15  NOVEMBER  2018 
The following communication, dated 22  November 2018, 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 (Cosmetics 5778 -2018)", notified as 
G/TBT/N/ISR/709/Add.2 on 23 January 2018. The European Union provided its comments to this 
addendum on 14 February 2018, however so far Israel has provided no reply.  
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 its comments o n important 
issues submitted to Israel in August 2017 have not been taken into account. Israel did not react to 
the EU 's comments. Therefore, the EU would like to call on the Israeli authorities to provide replies 
to the EU 's concerns expressed in August 2 017 and in February 2018.  
3.  The EU welcomes the Israeli initiative to move towards harmon isation 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.  The EU welc omes the fact that the Pharmacists Regulations introduces the notion of Responsible 
Person based on the EU approach. However, the new Pharmacists' Regulations (Cosmetics 5778 -
2018) refer to an actual person and not an entity. The EU is of the opinion that having all obligations 
of a Responsible Person to be fulfilled by one physical person will be very challenging for the company 
and the individual. Therefore, the EU would like to stress the fact that the new law should provide 
the option for the Responsibl e Person to be a legal entity.  
5.  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.  
6.  The new Pharmacists Regulations will requir e 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 the Israeli 
authorities to reconsider this new obligation.  
7.  The EU would like to propose removing or making optional the requirement to provide a barcode 
number according to the cosmetic p roduct's packaging.  
8.  As regards the availability of the Product Information File (PIF), the EU is of the opinion that all 
requirements going beyond the "readily available" approach would add additional burdens to 
companies seeking to operate in Israel with out providing additional protection to consumers' health. G/TBT/W/573  
 
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  We therefore propose that a first set of relevant information be made immediately available to Israeli 
authorities followed by a second set of additional information upon request within 72 hours.  
9.  Concerning the requirement for 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 clear disadvantage is already being observed for co mpanies based in those EU countries 
which do not have a competent authority delivering GMP certificates.  
10.  The EU would like to ask Israel for clarification on the enforcement of the rules for parallel 
importers provided for in the draft measure and what op tions, if any, main importers will have to 
seek redress if the rules are not followed.  
11.  The draft Israeli Regulation requires the notification of products containing nanomaterials six 
months prior to placing on the market. In the EU, such requirements do no t 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 
favourable opinion (in their nano form) f rom the EU Scientific Committee for Consumer Safety 
(SCCS). The EU strongly recommends following this approach in which the pre -notification process 
applies only for new nanomaterials that are not yet listed in any Annex of the EU Cosmetics 
Regulation.  
12.  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 lea st 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 system was introduced 
in the EU in 2013, it entered into force after a 3.5 year transition period (the EU Cosmetics Regulation 
was published in 2009).  
13.  The EU would like to ask Israel once more to take the above comments into account, and to 
provide replies to the issues previously raised.  
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