G/TBT/N/LTU/29  
 
9 January 2017  
(17-0088) 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 : LITHUANIA   
If applicable, name of local government involved  (Article 3.2 and 7.2) :  
2. Agency responsible:  Ministry of Health of the Republic  of Lithuania.  
Name and address (including telephone 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 :  
Ministry of Healt h of the Republic of Lithuania: http://www.sam.lt   
Vilniaus str. 33,  
LT-01506 Vilnius, Lithuania  
Telephone +370 5 266 1400  
Fax: +370 5 266 1402  
E-mail: regina.burbiene@sam.lt ; enquiry@lsd.lt  
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 additi on, where applicable):  Cosmetic products. 
Defined categories of cosmetic products which are relevant for the application of 
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 
30 November 2009 on cosmetic products (face, lips, ski n eyes, nails, oral and similar 
products).  
5. Title, number of pages  and language(s)  of the notified document:  Draft Order of the 
Minister for Health of the Republic of Lithuania amending Order No 288 of the Minister for 
Health of the Republic of Lithuani a of 15 May 2001 approving Lithuanian Hygiene Norm 
HN 64-1:2001 .  
Cosmetic products and personal hygiene products: maximum permissible level of microbial 
contamination  (5 pages, in English)   
6. Description of content:  The objective of Hygiene Norm is to d efine microbiological 
qualitative and quantitative limits for finished cosmetic products in order to ensure their 
microbiological safety. Microbiological limits are based on the Lithuanian standard 
LST EN ISO 17516:2015 Cosmetics  Microbiology  - Microbiolo gical limits (ISO 17516:2014) 
and the 9th Revision of SCCS Notes of Guidance for the Testing of Cosmetic Ingredients 
and Their Safety Evaluation. Two separate categories of cosmetic products are defined: 
Category 1: products specifically intended for child ren under 3 years and care products of 
eyes, mucous membranes and Category 2: products, not involved in Category 1.  
The probability of microbiological contamination for some cosmetic products is extremely 
low due to product characteristics to create a hos tile environment for survival or growth of 
microorganisms. Responsible person (manufacturer, distributor, importer) has obligation to 
perform a microbiological risk assessment of the cosmetic products and to identify 
microbiologically low -risk products, wh ose environment denies the physical and chemical 
requirements for growth or survival of microorganisms. Therefore, products that comply 
with the characteristics outlined in Lithuanian standard LST EN ISO 29621:2011 Cosmetics G/TBT/N/LTU/29  
 
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  - Microbiology - Guidelines for  the risk assessment and identification of microbiologically 
low-risk products (ISO 29621:2010) do not require routine microbiological testing. In the 
suspected cases of microbiological contamination of microbiologically low - risk products 
market surveilla nce authorities, in accordance with the requirements of legal act must 
organize microbiological testing which should be provided by accredited testing laboratory.  
7. Objective and rationale , including the nature of urgent problems where applicable: 
Protection of human health or safety  
8. Relevant documents:  ISO 29621:2010 Cosmetics - Microbiology - Guidelines for the risk 
assessment and identification of microbiologically low -risk products, ISO 17516:2014 
Cosmetics - Microbiology - Microbiological limits , 9th Revision of SCCS Notes of Guidance 
for the Testing of Cosmetic Ingredients and Their Safety Evaluation.   
9. Proposed date of adoption: Not specified.  
Proposed date of entry into force: Not specified.  
10. Final date for comments:  60 days from not ification  
11. Texts available from : National enquiry point  [X] or address, telephone and fax 
number s and e mail and website address es, if available , of other body:   
National Enquiry Point: enquiry@lsd.lt