Proposal for a Council Regulation amending Annex I to Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff
Date: 2006-11-17
Institutions: European Commission
Subjects: Combined Nomenclature, common customs tariff, medical device, pharmaceutical product, suspension of customs duties, tariff nomenclature

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 17.11.2006 
COM(2006)696 final 

Proposal for a 

COUNCIL REGULATION 

amending Annex I to Regulation (EEC) No 2658/87 on the tariff and statistical 
nomenclature and on the Common Customs Tariff 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

1) 

CONTEXT OF THE PROPOSAL 

•  Grounds for and objectives of the proposal 

The  aim  of  this  draft  Council  Regulation  is  to  suspend  customs  duty  autonomously  for  an 
indefinite  period,  on  certain  goods  contained  in  Chapter  30  (pharmaceutical  products),  and 
hence amend Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature 
and on the Common Customs Tariff. 

•  General context 

(1) 

(2) 

(3) 

(4) 

(5) 

Chapter 30 of the Combined Nomenclature (CN) covers pharmaceutical products. 

Sterile  surgical  or  dental  adhesion  barriers,  whether  or  not  absorbable,  are,  in  2006, 
classified  in  chapter  39  or  60  (according  to  their  constituent  material)  of  the  2002 
version  of  the  Harmonised  System.  Appliances  identifiable  for  ostomy  use  are,  in 
2006, classified in chapter 39 of the 2002 version of the Harmonised System. Those 
products are subject to a 6,5% customs duty. 

Such  products  will  be  classifiable,  from  1  January  2007,  in  Chapter  30  of  the 
Combined Nomenclature following the transposition of the CN into the HS 2007 (as a 
result  of  the  amendments  to  the  nomenclature  appended  as  an  annex  to  the 
International  Convention  on  the  Harmonized  Commodity  Description  and  Coding 
System  accepted  pursuant  to  the  Recommendation  of  26  June  2004  of  the  Customs 
Co-operation Council). 

As  an  outcome  of  the  Uruguay  Round  negotiations  on  pharmaceutical  products, 
Chapter 30 is free of customs duties. 

On public health grounds, it is of the Community interest to autonomously extend this 
exemption from customs duties to these products. 

•  Existing provisions in the area of the proposal 

Council  Regulation  (EEC)  No  2658/87  on  the  tariff  and  statistical  nomenclature  and  on  the 
Common Customs Tariff. 

•  Consistency with other policies and objectives of the Union 

In line with, trade, enterprise, health and external relations policies.  

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2) 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

•  Consultation of interested parties 

Consultation methods, main sectors targeted and general profile of respondents 

The Tariff and Statistical Nomenclature Section (CN sector) of the Customs Code Committee.  

Summary of responses and how they have been taken into account 

The suspension corresponds to the agreement of the consultation of the group. 

•  Collection and use of expertise 

Scientific/expertise domains concerned 

Customs Experts representing the MS on the Customs Code Committee. 

Methodology used 

Meetings. 

Main organisations/experts consulted 

Experts designated by each of the MS. 

Summary of advice received and used 

The  existence  of  potentially  serious  risks  with  irreversible  consequences  has  not  been 
mentioned. 

Means used to make the expert advice publicly available 

Publication of the Proposal. 

•  Impact assessment 

Inter service consultation. 

Health benefit. 

3) 

LEGAL ELEMENTS OF THE PROPOSAL 

•  Summary of the proposed action 

Proposal  for  a  COUNCIL  REGULATION  amending  Annex  I  of  Regulation  (EEC) 
No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff.  

•  Legal basis 

Art 26 of the Treaty. 

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•  Subsidiarity principle 

The  proposal  falls  under  the  exclusive  competence  of  the  Community.  The  subsidiarity 
principle therefore does not apply. 

•  Proportionality principle 

The proposal complies with the proportionality principle for the following reason(s). 

Not applicable. 

This set of measures is in line with the principles  set out to simplify the  procedures for the 
operators engaged in foreign trade. 

•  Choice of instruments 

Proposed instruments: regulation. 

Other means would not be adequate for the following reason(s). 

By  virtue  of  Article  26  of  the  EC  Treaty  autonomous  tariff  suspensions  and  quotas  are 
approved  by  the  Council  acting  on  a  qualified  majority  on  the  basis  of  a  Commission 
proposal. 

4) 

BUDGETARY IMPLICATION 

Uncollected customs duties. 

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Proposal for a 

COUNCIL REGULATION 

amending Annex I to Regulation (EEC) No 2658/87 on the tariff and statistical 
nomenclature and on the Common Customs Tariff 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article 26 thereof, 

Having regard to the proposal from the Commission1, 

Whereas: 

(1) 

(2) 

Following  the  negotiations  in  the  framework  of  the  Uruguay-Round,  provision  was 
made  in  the  Combined  Nomenclature  (CN),  laid  down  in  Annex  I  to  Council 
Regulation (EEC) No 2658/872, for an exemption from tariff duties for pharmaceutical 
products falling under Chapter 30. 

Sterile surgical or dental adhesion barriers, whether or not absorbable, and appliances 
identifiable  for  ostomy  use,  are  classified  currently  in  different  chapters  of  the 
Combined  Nomenclature  and  are  subject  to  a  6,5%  rate  of  duty.  However,  after  1 
January 2007, they are to be classified in Chapter 30 of the Combined Nomenclature 
as  a  result  of  the  amendments  to  the  Nomenclature  appended  as  an  annex  to  the 
International  Convention  on  the  Harmonized  Commodity  Description  and  Coding 
System,  accepted  pursuant  to  the  Recommendation  of  26  June  2004  of  the  Customs 
Co-operation Council. 

(3) 

For reasons of public health, it is in the Community interest to extend autonomously to 
those goods the exemption for pharmaceutical products falling under Chapter 30. That 
should be done by means of a suspension of duties for an indefinite period. 

(4) 

Regulation (EEC) No 2658/87 should therefore be amended accordingly. 

(5) 

Since  the  amendment  introduced  by  this  Regulation  is  to  be  applied  from  the  same 
date  as  the  Combined  Nomenclature  for  2007,  laid  down  in  Regulation  (EC) 
No 1549/2006,  this  Regulation  should  enter  into  force  immediately  and  apply  from 
1 January 2007, 

1 
2 

OJ C […] […], p. […] 
OJ L 256, 7.9.1987. Regulation as last amended by Commission Regulation (EC) No 1549/2006 (OJ L 
301, 31.10.2006, p. 1). 

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HAS ADOPTED THIS REGULATION: 

Article 1 

Section  VI,  Chapter  30  of  Part  Two  (Schedule  of  Duties)  of  Annex  I  to  Council 
Regulation (EEC) No 2658/87 is amended as follows: 

in the entry for heading CN 3006 10 30, the text in the third column is replaced by the 

(a) 
following: 

___________________ 
* 

Customs duty autonomously suspended for an indefinite period." 

“6,5* 

(b) 

in the entry for heading 3006 91 00, the text in the third column is replaced by the 
following: 

___________________ 
* 

Customs duty autonomously suspended for an indefinite period." 

“6,5* 

Article 2 

This Regulation shall enter into force on the day of its publication in the Official Journal of 
the European Union. 

It shall apply from 1 January 2007. 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels,  

For the Council 
The President 

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LEGISLATIVE FINANCIAL STATEMENT FOR PROPOSALS HAVING A 
BUDGETARY IMPACT EXCLUSIVELY LIMITED TO THE REVENUE SIDE 

1. 

NAME OF THE PROPOSAL : 

Proposal  for  a  Council  Regulation  amending  Annex  I  to  Regulation  (EEC)  No 
2658/87  on  the  tariff  and  statistical  nomenclature  and  on  the  Common  Customs 
Tariff 

2. 

BUDGET LINES : 

Chapter and Article: Chap. 12 art. 120 

3. 

FINANCIAL IMPACT  

(cid:133) 

Proposal has no financial implications 

Proposal has no financial impact on expenditure but has a financial impact on 

X 
revenue – the effect is as follows: 

It  is  very  difficult  to  estimate  the  loss  of  own  resources  involved.  No  precise 
statistics for these two categories of products are available at import because they are 
classified, in 2006, in different residual subheadings where the trade volume is very 
high. 

On the basis of the imports realized in 2005, the maximum loss of revenue has been 
estimated to EURO 1.104. 000 (before deduction of the 25 %) for the two products, 
which is  the estimated loss  for  2005  of  goods, similarly transferred in the previous 
HS exercise.  

(€ million to one decimal place) 

Budget line 

Revenue3 

starting 

Article 120 

Impact on own resources 

1/1/2007 

[Year n] 

828.000 

4. 

ANTI-FRAUD MEASURES 

Application of the normal measures foreseen under the Community Customs Code. 

5. 

OTHER REMARKS 

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Regarding  traditional  own  resources  (agricultural  duties,  sugar  levies,  customs  duties)  the  amounts 
indicated must be net amounts, i.e. gross amounts after deduction of 25 % of collection costs. 

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