Procedure File: 2012/0267(COD) | Legislative Observatory

Basic information

Basic information

2012/0267(COD)

COD - Ordinary legislative procedure (ex-codecision procedure)

Regulation

Repealing Directive 98/79/EC 1995/0013(COD)
Amended by 2021/0323(COD)
Amended by 2023/0005(COD)
Amended by 2024/0021(COD)
See also 2012/0266(COD)

Subject

2.10.03 Standardisation, EC/EU standards and trade mark, certification, compliance
3.40.11 Precision engineering, optics, photography, medical
4.20.05 Health legislation and policy
4.60.08 Safety of products and services, product liability

Status

Procedure completed

Please go to Documentation gateway for any follow-up documents.

Key players

Key players

European Parliament

Committee responsible	Rapporteur	Appointed
ENVI Environment, Public Health and Food Safety	LIESE Peter (PPE)	24/10/2012
	ROTH-BEHRENDT Dagmar (S&D) TAYLOR Rebecca (ALDE) AUKEN Margrete (Verts/ALE) CABRNOCH Milan (ECR)

Former committee responsible

Former committee responsible	Former rapporteur	Appointed
ENVI Environment, Public Health and Food Safety	LIESE Peter (PPE)	24/10/2012

Former committee for opinion

Former committee for opinion	Former rapporteur for opinion	Appointed
INTA International Trade	The committee decided not to give an opinion.
EMPL Employment and Social Affairs	ESTRELA Edite (S&D)	21/11/2012
ITRE Industry, Research and Energy	The committee decided not to give an opinion.
IMCO Internal Market and Consumer Protection	BERRA Nora (PPE)	10/10/2012

Council of the European Union

Council configuration	Meetings	Date
General Affairs	3484	20/09/2016
General Affairs	3525	07/03/2017
Employment, Social Policy, Health and Consumer Affairs	3206	06/12/2012
Employment, Social Policy, Health and Consumer Affairs	3475	16/06/2016
Employment, Social Policy, Health and Consumer Affairs	3323	19/06/2014
Employment, Social Policy, Health and Consumer Affairs	3280	09/12/2013
Employment, Social Policy, Health and Consumer Affairs	3351	01/12/2014

European Commission

Commission DG	Commissioner
Health and Food Safety	MIMICA Neven

- European Economic and Social Committee
- European Committee of the Regions

Key events

Key events

Date	Event	Reference
26/09/2012	Legislative proposal published	COM(2012)0541
22/10/2012	Committee referral announced in Parliament, 1st reading
06/12/2012	Debate in Council
25/09/2013	Vote in committee, 1st reading
10/10/2013	Committee report tabled for plenary, 1st reading	A7-0327/2013
22/10/2013	Decision by Parliament, 1st reading	T7-0427/2013
22/10/2013	Results of vote in Parliament
22/10/2013	Debate in Parliament
09/12/2013	Debate in Council
02/04/2014	Decision by Parliament, 1st reading	T7-0267/2014
19/06/2014	Debate in Council
05/11/2014	Committee decision to open interinstitutional negotiations after 1st reading in Parliament
01/12/2014	Debate in Council
16/06/2016	Debate in Council
20/09/2016	Debate in Council
08/03/2017	Council position published	10729/4/2016
16/03/2017	Committee referral announced in Parliament, 2nd reading
21/03/2017	Vote in committee, 2nd reading
23/03/2017	Committee recommendation tabled for plenary, 2nd reading	A8-0069/2017
04/04/2017	Debate in Parliament
05/04/2017	Decision by Parliament, 1st reading	T8-0108/2017
05/04/2017	Final act signed
05/04/2017	End of procedure in Parliament
05/05/2017	Final act published in Official Journal

Technical information

Technical information

Procedure	Information
Procedure reference	2012/0267(COD)
Procedure type	COD - Ordinary legislative procedure (ex-codecision procedure)
Nature of procedure	Legislation
Legislative instrument	Regulation
	Repealing Directive 98/79/EC 1995/0013(COD) Amended by 2021/0323(COD) Amended by 2023/0005(COD) Amended by 2024/0021(COD) See also 2012/0266(COD)
Legal basis	Treaty on the Functioning of the EU TFEU 168-p4 Treaty on the Functioning of the EU TFEU 114-p1
Other legal basis	Rules of Procedure EP 165
Mandatory consultation of other institutions	European Economic and Social Committee European Committee of the Regions
Stage reached in procedure	Procedure completed
Committee dossier	ENVI/8/06746

Documentation gateway

Documentation gateway

European Parliament

Document type	Committee	Reference	Date
Committee draft report		PE506.196	03/04/2013
Amendments tabled in committee		PE510.535	26/04/2013
Amendments tabled in committee		PE510.668	07/05/2013
Amendments tabled in committee		PE510.740	14/05/2013
Amendments tabled in committee		PE510.755	14/05/2013
Committee opinion	IMCO	PE508.086	20/06/2013
Committee opinion	EMPL	PE506.246	02/07/2013
Committee report tabled for plenary, 1st reading/single reading		A7-0327/2013	10/10/2013
Text adopted by Parliament, partial vote at 1st reading/single reading		T7-0427/2013	22/10/2013
Text adopted by Parliament, 1st reading/single reading		T7-0267/2014	02/04/2014
Committee draft report		PE601.101	15/03/2017
Committee recommendation tabled for plenary, 2nd reading		A8-0069/2017	23/03/2017
Text adopted by Parliament, 2nd reading		T8-0108/2017	05/04/2017

Council of the EU

Document type	Reference	Date
Council statement on its position	06593/1/2017	06/03/2017
Council position	10729/4/2016	08/03/2017
Draft final act	00015/2017/LEX	05/04/2017

European Commission

Document type	Reference	Date
Legislative proposal	COM(2012)0541	26/09/2012
Document attached to the procedure	COM(2012)0540	26/09/2012
Document attached to the procedure	SWD(2012)0274	26/09/2012
Document attached to the procedure	SWD(2012)0273	26/09/2012
Commission response to text adopted in plenary	SP(2014)471	09/07/2014
Commission communication on Council's position	COM(2017)0127	09/03/2017

National parliaments

Document type	Parliament/Chamber	Reference	Date	Summary
Contribution	IT_SENATE	COM(2012)0541	25/10/2012
Contribution	PT_PARLIAMENT	COM(2012)0541	28/11/2012

Additional information

Additional information

Source	Document	Date
EP Research Service	Briefing
National parliaments	IPEX
European Commission	EUR-Lex

Final act

Final act

Delegated acts

Delegated acts

Reference	Subject
2022/2985(DEA)	Examination of delegated act