G/TBT/W/473  
 
17 April 2018  
(18-2328) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
 ISRAEL — ADDENDUM TO THE PHAR MACIST REGU LATIONS (COSMETICS 5 778-2018)  
STATEMENT BY THE EUR OPEAN UNION TO THE C OMMITTEE ON TECHNICA L BARRIERS TO TRADE  
21 AND 22 MARCH 2018  
The following communication, dated 16 April 2018, is being circulated at the request of the 
delegation of the European Union . 
 
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1.  The European Union would like to thank the Israeli authorities for providing the opportunity to 
comment on the "Addendum to the Pharmacist Regulatio ns (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.  The EU welcomes the Israeli initiative to move tow ards 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.  
3.  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. After the assessment of the newly 
notified Addendum 2, the EU is concerned that comments on important issues submitted to Israel 
in August 2017 have not been taken into account. The EU has not rece ived any reply from Israel. 
Therefore, the EU would like to call on Israeli authorities to provide replies to EU 's concerns 
expressed in August 2017 and February 2018.  
4.  The EU welcomes the fact that the Pharmacists Regulation introduces the notion of Respon sible 
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 h aving all 
obligations of 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 Responsible Person  to be a legal entity.  
5.  Given that the two above -mentioned sets of EU com ments 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 also require the Responsible Person  to submit quar terly 
reports for every product whic h is not in line with the EU Cosmetics Regulation . The EU is 
concerned  that this requirement w ould be very challenging and time consuming for companies 
without providing add itional  protection to consumers. The Product Information File (PIF)  is a liv ing 
document whereby the information is systematically updated, and most of the time kept in an 
electronic format. For these reasons, the EU finds it excessive to oblige the companies to produce 
a quarterly report as it impose s additional administrative burde ns on the R esponsible Person . The 
EU would therefore like to recommend to Israeli authorities to reconsider this new obligation . 
7.  The EU would like to propose to remove or make optional the requirement to provide  a barcode 
number  according to the cosmetic p roduct's packaging.   G/TBT/W/473  
 
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  8.  As regards the availability of the Product Information File (PIF), the EU is of the opinion that all 
requirements go ing beyond the "readily available " approach would add additional burdens to 
companies seeking to operate in Israel with out providing additional protection to consumer s' 
health. 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 Cosmetic s Regulation or any international practice across the 
world. The EU Cosmetics Regulation specifically mentions GMP self -certification and thus obliging 
an authority or other bod y documentation on this issue w ould be very challenging and create 
barriers  to trade .  
10.  The EU  would like to ask Israel for  clarification s on the enforcement of the rules for parallel 
importers foreseen in the draft measure and what options, if any, main importers will have to seek 
redress if the rules are not followed . 
11.  The draft Israeli Regulation requires notifying products containing nanomaterials six months 
prior to placing on the market. The EU understands  that these requirements shall apply  both for 
new nanomaterials and for established ones that are already listed in the Annexes of the EU 
Cosmetics Regulation . In the EU, such requirement s do not apply to nanomaterials already listed in 
Annexes III to VI of the EU Cosmetics Regulation. The inclusion  of nanomaterials i n the EU 
Annexes already means  that they have under gone very extensive risk assessment  and have a 
favourable opinion ( in their nano form) from the EU Scientific Committee for Con sumer Safety 
(SCCS). The EU strongly  recommend s following this approach where the pre-notification process  
applies  only f or 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 . Although the new requirements are based on EU 
rules, the EU  would like to recommend a transition period of at least one year to implement the 
new legislation a nd at least six months after the notification portal is fully functional, to ensure 
that companies comply with the new requirements and that b lockages are avoided at the borders. 
It is important to note that when the notification system 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).   
13.  The EU would like to ask once more Israel to take the above comments into account , and to 
provide replies to the issues raised.  
 
 
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