G/TBT/N/EU/258
15 January 2015 
(15-0274)  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: EUROPEAN UNION 
If applicable, name of local government involved (Article 3.2 and 7.2):    
2. Agency responsible: European Commission 
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 : 
European Commission 
EU-TBT Enquiry Point 
Fax: +(32) 2 299 80 43 E-mail: eu-tbt@ec.europa.eu   
Website: http://ec.europa.eu/enterprise/tbt/   
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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Electrical and electronic 
equipment 
5. Title, number of pages and langua ge(s) of the notified document: Draft Commission 
Delegated Directive amending, for the purposes of adapting to technical progress, Annex IV 
to Directive 2011/65/EU of the European Parliament and of the Council as regards an 
exemption for lead in polyvinyl chloride sensors in in-vitro diagnostic medical devices (6 pages + Annex 2 pages, in English) 
6. Description of content: This draft Commission Delegated Directive concerns an 
application specific and temporary exemption from the RoHS 2 (Directive 2011/65/EU) substance restrictions.  
7. Objective and rationale, including the nature of urgent problems where applicable: 
Adaptation of existing legislation to scientific and technical progress, granting 
manufacturers adequate transition time for compliance. 
8. Relevant documents:   
• Scientific background studies justifying the specific exemption are available via the 
Commission consultants' project webpage (pages 27-39) http://rohs.exemptions.oeko.info/fileadm in/user_upload/RoHS_IX/20140422_RoHS2
_Evaluation_Ex_Requests_2013-1-5_final.pdf   
• Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 
on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88–110) http://eur-
lex.europa.eu/legal-content/EN/TXT/?qid=1418640228575&uri=CELEX:32011L0065  G/TBT/N/EU/258 
 
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  9. Proposed date of adoption:   January 2015 
Proposed date of entry into force:   20 days from publication in  the Official Journal of the 
EU (about three months after adoption approx.)   
10. Final date for comments: Not applicable. The notified draft is a technical adaptation 
exercise and does not pose additional burden on economic operators; it is considered to 
have a trade-enhancing effect. 
11. Texts available from: Nati onal enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
European Commission 
EU-TBT Enquiry Point Fax: + (32) 2 299 80 43 
E-mail: eu-tbt@ec.europa.eu   
The text is available on the EU-TBT Website:  http://ec.europa.eu/enterprise/tbt/   
https://members. wto.org/crnattachments/2015/TBT/EEC/15_0244_00_e.pdf  
https://members. wto.org/crnattachments/2015/TBT/EEC/15_0244_01_e.pdf