Date: 2016-11-19Category: Not ApplicableState: Union GovernmentCountry: Europe
Decision No 1/2016 of the EU-Republic of Moldova Association Committee in Trade configuration of 19 October 2016 updating Annex XVI to the Association Agreement [2016/2027]
Executive Summary:
This document outlines Decision No 1/2016 of the EU-Republic of Moldova Association Committee in Trade Configuration, updating Annex XVI to the Association Agreement. The update reflects amendments, recasts, and repeals of Union acts to align Moldovan legislation with EU standards. Key deadlines for approximation of national legislation to new Union acts have been extended, with the decision entering into force on the day of its adoption, October 19, 2016.
Key Points / Main Content:
* **Purpose:** To update Annex XVI of the Association Agreement between the EU and the Republic of Moldova to reflect changes in Union legislation.
* **Updated Annex XVI Sections:**
* Horizontal legislative framework for marketing of products
* Legislation based on the principles of the new approach which provide for CE marking
* Directives based on the principles of the New Approach or the Global Approach, but which do not provide for CE marking
* Two or three-wheel motor vehicles and Wheeled agricultural or forestry tractors of Section Construction of motor vehicles
* REACH and REACH implementation, Dangerous chemicals and Classification, packaging and labelling of Section Chemicals
* **Key Legislative Updates:** Includes updates to regulations and directives concerning:
* Marketing of products
* Electrical equipment
* Pressure vessels
* Electromagnetic compatibility
* Explosive atmospheres
* Explosives for civil uses
* Lifts and safety components
* Measuring instruments
* Non-automatic weighing instruments
* Pressure equipment
* Radio equipment
* Recreational craft
* Pyrotechnic articles
* Transportable pressure equipment
* Two/three-wheel vehicles and quadricycles
* Agricultural and forestry vehicles
* Hazardous chemicals
* Major-accident hazards involving dangerous substances
* Waste electrical and electronic equipment
* **Deadlines for Approximation:**
* Specifies deadlines for the Republic of Moldova to approximate its national legislation to the updated Union acts, with some deadlines extended.
* Some deadlines are aligned to Annex IV (Consumer Protection) and Annex XI (Environment) of the Agreement.
Impact Analysis:
* **Republic of Moldova:**
* *Impact:* Must align its national legislation with the updated EU legislation as outlined in the revised Annex XVI of the Association Agreement. This includes adopting and implementing the specific directives and regulations listed in the annex within the specified timeframes.
* *Action Required:* Transpose the updated EU legislation into Moldovan law, ensuring compliance with the specified deadlines.
* **Manufacturers and Importers (Operating in or Trading with Moldova):**
* *Impact:* Need to adapt to the new regulations and standards incorporated into Moldovan law as a result of the updated Annex XVI. This may involve changes to product design, manufacturing processes, and conformity assessment procedures to meet the requirements for placing products on the Moldovan market.
* *Action Required:* Familiarize themselves with the updated regulations and standards, assess the impact on their products and processes, and implement necessary changes to ensure compliance.
* **European Union:**
* *Impact:* Ensuring the Republic of Moldova aligns its legislation with EU standards, thereby facilitating trade and cooperation.
* *Action Required:* Monitor the Republic of Moldova's progress in approximating its legislation and provide assistance as needed.
Key Entities Referenced
Republic of Moldova: A country in Eastern Europe that is party to the Association Agreement with the European Union and the European Atomic Energy Community.
European Union: A political and economic union of member states located primarily in Europe.
European Atomic Energy Community: An international organization established by the Treaty of Rome in 1958 with the purpose of creating a specialist market for nuclear power in Europe.
Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part: A trade and political agreement between the EU, the European Atomic Energy Community, and Moldova.
Annex XVI to the Association Agreement: An annex to the Association Agreement that lists Union laws with which the Republic of Moldova shall gradually achieve conformity.
Regulation EC No 765/2008: Regulation of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products.
Regulation EC No 1907/2006 REACH: A European Union regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals.
Directive 2012/18/EU: Directive of the European Parliament and of the Council on the control of major-accident hazards involving dangerous substances.
L 313/28 EN Official Journal of the European Union 19.11.2016
ACTS ADOPTED BY BODIES CREATED BY
INTERNATIONAL AGREEMENTS
DECISION No 1/2016 OF THE EU-REPUBLIC OF MOLDOVA ASSOCIATION COMMITTEE IN
TRADE CONFIGURATION
of 19 October 2016
updating Annex XVI to the Association Agreement [2016/2027]
THE ASSOCIATION COMMITTEE IN TRADE CONFIGURATION,
Having regard to the Association Agreement between the European Union and the European Atomic Energy Community
and their Member States, of the one part, and the Republic of Moldova, of the other part, and in particular Article 173
and Article 436 thereof,
Whereas:
(1) The Association Agreement between the European Union and the European Atomic Energy Community and their
Member States of the one part, and the Republic of Moldova, of the other part (1) (‘the Agreement’) entered into
force on 1 July 2016.
(2) In accordance with Article 173 of the Agreement the Republic of Moldova shall gradually achieve conformity
with the relevant Union acquis, in accordance with the provisions of Annex XVI to the Agreement.
(3) Several Union acts listed in Annex XVI to the Agreement have been amended, recast or repealed and replaced by
new Union acts since the initialling of the Agreement on 29 November 2013. In particular, the Union adopted
and notified to the Republic of Moldova the following acts:
(a) Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonis
ation of the laws of the Member States relating to the making available on the market of electrical
equipment designed for use within certain voltage limits (2);
(b) Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonis
ation of the laws of the Member States relating to the making available on the market of simple pressure
vessels (3);
(c) Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonis
ation of the laws of the Member States relating to electromagnetic compatibility (4);
(d) Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonis
ation of the laws of the Member States relating to equipment and protective systems intended for use in
potentially explosive atmospheres (5);
(e) Directive 2014/28/EU of the European Parliament and of the Council of 26 February 2014 on the harmonis
ation of the laws of the Member States relating to the making available on the market and supervision of
explosives for civil uses (6);
(f) Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonis
ation of the laws of the Member States relating to lifts and safety components for lifts (7);
(1) OJ L 260, 30.8.2014, p. 4.
(2) OJ L 96, 29.3.2014, p. 357.
(3) OJ L 96, 29.3.2014, p. 45.
(4) OJ L 96, 29.3.2014, p. 79.
(5) OJ L 96, 29.3.2014, p. 309.
(6) OJ L 96, 29.3.2014, p. 1.
(7) OJ L 96, 29.3.2014, p. 251.19.11.2016 EN Official Journal of the European Union L 313/29
(g) Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonis
ation of the laws of the Member States relating to the making available on the market of measuring
instruments (1);
(h) Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonis
ation of the laws of the Member States relating to the making available on the market of non-automatic
weighing instruments (2);
(i) Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation
of the laws of the Member States relating to the making available on the market of pressure equipment (3);
(j) Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisa
tion of the laws of the Member States relating to the making available on the market of radio equipment and
repealing Directive 1999/5/EC (4);
(k) Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational
craft and personal watercraft and repealing Directive 94/25/EC (5);
(l) Directive 2013/29/EU of the European Parliament and of the Council of 12 June 2013 on the harmonisation
of the laws of the Member States relating to the making available on the market of pyrotechnic articles (6);
(m) Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable
pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC
and 1999/36/EC (7);
(n) Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the
approval and market surveillance of two- or three-wheel vehicles and quadricycles (8);
(o) Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the
approval and market surveillance of agricultural and forestry vehicles (9);
(p) Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the
export and import of hazardous chemicals (10);
(q) Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the control of
major-accident hazards involving dangerous substances, amending and subsequently repealing Council
Directive 96/82/EC (11);
(r) Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and
electronic equipment (WEEE) (12).
(4) Certain Union acts listed in Annex XVI are also listed in Annex IV (Consumer Protection) and Annex XI
(Environment) to the Agreement. In the interest of clarity, the applicable deadlines for approximation of those
acts listed in Annex XVI should be aligned to the deadlines specified in Annex IV (Consumer Protection) and
Annex XI (Environment) to the Agreement.
(5) It is necessary to update Annex XVI to the Agreement in order to reflect the evolution of the Union legislation
listed in that Annex, in accordance with Article 436(3) of the Agreement. In the interest of clarity, the sections of
Annex XVI to the Agreement affected by the changes should be updated in their entirety.
(6) The Republic of Moldova continues the process of approximating its legislation to the Union legislation, in
accordance with the timetable and priorities set out in Annex XVI to the Agreement. It is therefore appropriate to
ensure that the recent updates to the Union legislation are promptly and efficiently integrated in the ongoing
process of approximation and take into account the progress already made by the Republic of Moldova.
(1) OJ L 96, 29.3.2014, p. 149.
(2) OJ L 96, 29.3.2014, p. 107.
(3) OJ L 189, 27.6.2014, p. 164.
(4) OJ L 153, 22.5.2014, p. 62.
(5) OJ L 354, 28.12.2013, p. 90.
(6) OJ L 178, 28.6.2013, p. 27.
(7) OJ L 165, 30.6.2010, p. 1.
(8) OJ L 60, 2.3.2013, p. 52.
(9) OJ L 60, 2.3.2013, p. 1.
(10) OJ L 201, 27.7.2012, p. 60.
(11) OJ L 197, 24.7.2012, p. 1.
(12) OJ L 197, 24.7.2012, p. 38.L 313/30 EN Official Journal of the European Union 19.11.2016
(7) It is appropriate to provide for transition periods to the Republic of Moldova in order to reflect the new Union
acts in its national legislation and to provide an adaptation period to the manufacturers and importers.
Accordingly, the deadlines for approximation of its national legislation to those new Union acts should be
extended.
(8) In accordance with Article 436(3) of the Agreement the EU-Republic of Moldova the Association Council shall
have the power to update or amend the Annexes to the Agreement. The Association Council empowered the
Association Committee in Trade configuration by Decision No 3/2014 of 16 December 2014 to update or
amend certain trade-related annexes,
HAS ADOPTED THIS DECISION:
Article 1
Section ‘Horizontal legislative framework for marketing of products’; Section ‘Legislation based on the principles of the
new approach which provide for CE marking’; Section ‘Directives based on the principles of the New Approach or the
Global Approach, but which do not provide for CE marking’; Subsection 2 ‘Two- or three-wheel motor vehicles’ and
Subsection 3 ‘Wheeled agricultural or forestry tractors’ of Section ‘Construction of motor vehicles’; Subsection 1
‘REACH and REACH implementation’, Subsection 2 ‘Dangerous chemicals’ and Subsection 3 ‘Classification, packaging
and labelling’ of Section ‘Chemicals’ of Annex XVI to the Association Agreement between the European Union and the
European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the
other part, are replaced by the text appearing in the Annex to this Decision.
Article 2
This Decision shall enter into force on the day of its adoption.
Done at Brussels, 19 October 2016.
For the Association Committee in Trade
configuration
P. SOURMELIS
The Chair19.11.2016 EN Official Journal of the European Union L 313/31
ANNEX
UPDATE OF ANNEX XVI TO THE AGREEMENT
Section ‘Horizontal legislative framework for marketing of products’; Section ‘Legislation based on the principles of the
new approach which provide for CE marking’; Section ‘Directives based on the principles of the New Approach or the
Global Approach, but which do not provide for CE marking’; Subsection 2 ‘Two- or three-wheel motor vehicles’ and
Subsection 3 ‘Wheeled agricultural or forestry tractors’ of Section ‘Construction of motor vehicles’; Subsection 1
‘REACH and REACH implementation’, Subsection 2 ‘Dangerous chemicals’ and Subsection 3 ‘Classification, packaging
and labelling’ of Section ‘Chemicals’ of Annex XVI to the Agreement are replaced by the following:
‘Union legislation Deadline for approximation
HORIZONTAL LEGISLATIVE FRAMEWORK FOR MARKETING OF PRODUCTS
Regulation (EC) No 765/2008 of the European Parliament and of the Council of Approximated on the date of en
9 July 2008 setting out the requirements for accreditation and market surveillance try into force of the Law No 235
relating to the marketing of products and repealing Regulation (EEC) No 339/93 of 1 December 2011
Decision No 768/2008/EC of the European Parliament and of the Council of
9 July 2008 on a common framework for the marketing of products, and repeal
ing Council Decision 93/465/EEC
Directive 2001/95/EC of the European Parliament and of the Council of 3 Decem 2016
ber 2001 on general product safety
Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, 2012
regulations and administrative provisions of the Member States concerning liability
for defective products
Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 2015
25 October 2012 on European standardisation, amending Council Directives
89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC,
97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of
the European Parliament and of the Council and repealing Council Decision
87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of
the Council
Council Directive 80/181/EEC of 20 December 1979 on the approximation of the 2015
laws of the Member States relating to units of measurement and on the repeal of
Directive 71/354/EEC, as amended by Directive 2009/3/EC of the European Parlia
ment and of the Council
LEGISLATION BASED ON THE PRINCIPLES OF THE NEW APPROACH WHICH PROVIDE FOR CE MARKING
Directive 2014/35/EU of the European Parliament and of the Council of 26 Febru 2017
ary 2014 on the harmonisation of the laws of the Member States relating to the
making available on the market of electrical equipment designed for use within
certain voltage limits
Directive 2014/29/EU of the European Parliament and of the Council of 26 Febru 2017
ary 2014 on the harmonisation of the laws of the Member States relating to the
making available on the market of simple pressure vesselsL 313/32 EN Official Journal of the European Union 19.11.2016
Regulation (EU) No 305/2011 of the European Parliament and of the Council of Full approximation: 2015
9 March 2011 laying down harmonised conditions for the marketing of construc
tion products and repealing Council Directive 89/106/EEC
Directive 2014/30/EU of the European Parliament and of the Council of 26 Febru 2017
ary 2014 on the harmonisation of the laws of the Member States relating to elec
tromagnetic compatibility
Council Directive 89/686/EEC of 21 December 1989 on the approximation of the Review and full approximation:
laws of the Member States relating to personal protective equipment 2015
Directive 2009/142/EC of the European Parliament and of the Council of 30 No Review and full approximation:
vember 2009 relating to appliances burning gaseous fuels 2016
Directive 2000/9/EC of the European Parliament and of the Council of 20 March 2015
2000 relating to cableway installations designed to carry persons
Directive 2014/34/EU of the European Parliament and of the Council of 26 Febru 2017
ary 2014 on the harmonisation of the laws of the Member States relating to
equipment and protective systems intended for use in potentially explosive atmos
pheres
Directive 2014/28/EU of the European Parliament and of the Council of 26 Febru 2017
ary 2014 on the harmonisation of the laws of the Member States relating to the
making available on the market and supervision of explosives for civil uses
Commission Decision 2004/388/EC of 15 April 2004 on an Intra-Community
transfer of explosives document
Commission Directive 2008/43/EC of 4 April 2008 setting up, pursuant to Coun
cil Directive 93/15/EEC, a system for the identification and traceability of explo
sives for civil uses
Directive 2014/33/EU of the European Parliament and of the Council of 26 Febru 2017
ary 2014 on the harmonisation of the laws of the Member States relating to lifts
and safety components for lifts
Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2015
2006 on machinery, and amending Directive 95/16/EC
Directive 2014/32/EU of the European Parliament and of the Council of 26 Febru 2017
ary 2014 on the harmonisation of the laws of the Member States relating to the
making available on the market of measuring instruments
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices Review and full approximation:
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws 2015
of the Member States relating to active implantable medical devices
Directive 98/79/EC of the European Parliament and of the Council of 27 October
1998 on in vitro diagnostic medical devices19.11.2016 EN Official Journal of the European Union L 313/33
Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new Full approximation: 2017
hot-water boilers fired with liquid or gaseous fuels
Directive 2014/31/EU of the European Parliament and of the Council of 26 Febru 2017
ary 2014 on the harmonisation of the laws of the Member States relating to the
making available on the market of non-automatic weighing instruments
Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2017
2014 on the harmonisation of the laws of the Member States relating to the mak
ing available on the market of pressure equipment
Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2017
2014 on the harmonisation of the laws of the Member States relating to the mak
ing available on the market of radio equipment and repealing Directive 1999/5/EC
Directive 2013/53/EU of the European Parliament and of the Council of 20 No 2018
vember 2013 on recreational craft and personal watercraft and repealing Directive
94/25/EC
Directive 2009/48/EC of the European Parliament and of the Council of 18 June Review and full approximation:
2009 on the safety of toys 2015
Directive 2013/29/EU of the European Parliament and of the Council of 12 June 2017
2013 on the harmonisation of the laws of the Member States relating to the mak
ing available on the market of pyrotechnic articles
DIRECTIVES BASED ON THE PRINCIPLES OF THE NEW APPROACH OR THE GLOBAL APPROACH, BUT WHICH DO
NOT PROVIDE FOR CE MARKING
European Parliament and Council Directive 94/62/EC of 20 December 1994 on 2015
packaging and packaging waste
Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2017
2010 on transportable pressure equipment and repealing Council Directives
76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC
CONSTRUCTION OF MOTOR VEHICLES
2. Two- or three-wheel motor vehicles
Regulation (EU) No 168/2013 of the European Parliament and of the Council of 2017
15 January 2013 on the approval and market surveillance of two- or three-wheel
vehicles and quadricyclesL 313/34 EN Official Journal of the European Union 19.11.2016
3. Wheeled agricultural or forestry tractors
Regulation (EU) No 167/2013 of the European Parliament and of the Council of 2016
5 February 2013 on the approval and market surveillance of agricultural and for
estry vehicles
Directive 2008/2/EC of the European Parliament and of the Council of 15 January 2016
2008 on the field of vision and windscreen wipers for wheeled agricultural or for
estry tractors
CHEMICALS
1. REACH and REACH implementation
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 2019
18 December 2006 concerning the Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH) and establishing a European Chemicals Agency,
amending Directive 1999/45/EC and repealing Council Regulation (EEC)
No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Di
rective 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC,
93/105/EC and 2000/21/EC
Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test 2019
methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament
and of the Council on the Registration, Evaluation, Authorisation and Restriction
of Chemicals (REACH)
2. Dangerous chemicals
Regulation (EU) No 649/2012 of the European Parliament and of the Council of 2017
4 July 2012 concerning the export and import of hazardous chemicals
Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2021
2012 on the control of major-accident hazards involving dangerous substances,
amending and subsequently repealing Council Directive 96/82/EC
Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2014
2011 on the restriction of the use of certain hazardous substances in electrical
and electronic equipment
Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2016
2012 on waste electrical and electronic equipment (WEEE)
Directive 2006/66/EC of the European Parliament and of the Council of 6 Septem 2013-14
ber 2006 on batteries and accumulators and waste batteries and accumulators and
repealing Directive 91/157/EEC19.11.2016 EN Official Journal of the European Union L 313/35
Council Directive 96/59/EC of 16 September 1996 on the disposal of polychlori Approximated in 2009
nated biphenyls and polychlorinated terphenyls (PCB/PCT)
Regulation (EC) No 850/2004 of the European Parliament and of the Council of 2013-14
29 April 2004 on persistent organic pollutants and amending Directive
79/117/EEC
3. Classification, packaging and labelling
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 2021’
16 December 2008 on classification, labelling and packaging of substances and
mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and
amending Regulation (EC) No 1907/2006