G/TBT/N/ISR/709  
 
23 October 2013  
(13-5861)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member:  ISRAEL  
If applicable, name of local government involved (Article 3.2 and 7.2):     
2. Agency responsible:  Israel WTO-TBT Enquiry Point 
Name and address (including telephon e and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above :   
Israel WTO-TBT Enquiry Point  
Ministry of Economy 
Tel.:  +(972) 3 7347502 Fax:  +(972) 3 7347626 E-mail:  Yael.Friedgut@moital.gov.il  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:   
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Cosmetics 
(HS: Chapter 33; ICS: 71.100.70). 
5. Title, number of pages and language(s) of the notified document:  Pharmacists' 
Regulations (Cosmetics) 5773-2013 (29 pages, in Hebrew). 
6. Description of content:  New draft regulations announced by Israel's Ministry of Health 
called " Pharmacists' Regulations (Cosmetics) ". This draft regulation fully adopts the 
European model for marketing of cosmetics outlined in " Regulation (EC) No. 1223/2009 of 
The European Parliament and of The Council of 30 November 2009 on Cosmetic Products ", 
which according to professionals provides the best basis for controlling the marketing of cosmetics, the lowering of trade barriers and safeguarding of consumers. 
The new regulations are significantly different from the way cosmetics had been controlled 
and supervised in Israel in the past. It does away with the supplier's need to obtain a registration certificate and requires only a notification 10 days prior to marketing. 
According to this change, the major responsibilities of the Ministry of Health will shift  to 
formulation of the rules and regulations for cosmetic marketing in Israel and determination of the bodies and mechanisms  authorized to manufacture and market cosmetics. All these 
will be accompanied by a strict market surveillance system. 
These are the major requirements introduced in the regulations:  -
 No person shall import into Israel a cosmetic unless the product has been granted a 
Certificate of Free Sale by a recognized country; 
- In order to establish clear responsibilities, each cosmetic product should be linked to a 
responsible person who will be the legal entity responsible for the product and for the regulatory procedures governing it (Regulation 5); 
-
 In order to ensure their safety, cosmetic products placed on the market should be 
produced according to Good Manufacturing Practice (GMP) and distributors shall G/TBT/N/ISR/709 
 
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  ensure that storage and transport conditions do not jeopardize their compliance with 
the requirements set out in these Regulations (Regulations 8 and 11); 
- Requires a safety assessment from a suitable professional that will cover all safety 
aspects of the cosmetic product, including its ingredients, side effects and required 
warnings (Regulation 12 and Annex 3); 
- For the purpose of effective market surveillance, a product information file should be 
made readily accessible to the competent authority and should include information 
and data about the product, its safety assessment, manufacturing procedures, tests, claims against it, if served, and data on any animal testing performed 
(Regulation 13); 
-
 Prior to placing the cosmetic product on the market, the responsible person shall 
provide the Ministry of Health electronically the general information required for the basic control by the Director General of the Ministry of Health or his representative 
(Regulation 14); 
- Establishmentof a National Cosmetics Poison Center which will hold full information 
about the cosmetic ingredients, including dosages, which may include confidential 
trade secrets that will be kept safe by the Ministry of Health. The information will be 
used only in case of an emergency for providing medical treatment to people affected by cosmetics (Regulation 26). 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health.  
8. Relevant documents:    
- Draft Pharmacists Regulations (Cosmetics) 5773-2013; 
- Products and Services Control Order (Cosmetics) 5733-1973; 
-  E C  R e g u l a t i o n  N o .  1 2 2 3 / 2 0 0 9  o f  T h e  E u r o p e a n  P a r l i a m e n t  a n d  o f  T h e  C o u n c i l  o f  
30 November 2009 on Cosmetic Products. 
9. Proposed date of adoption:   
Proposed date of entry into force:    To be determined 1 year from publication in Israel Official Gazette, section of government notice. 
10. Final date for comments:  60 days from date of notification. 
11. Text available from:  National enquiry point [ X], or address, telephone and fax 
numbers, e-mail and web-site addresse s, if available of the other body:   D r a f t  
Pharmacists Regulations (Cosmetics) 5773-2013 (Hebrew) http://www2.moital.gov.il/cmstamat/rsrc/tkina/PharmacistsRegulations-Cosmetics.pdf