Procedure File: 2012/0266(COD) | Legislative Observatory

Basic information

Basic information

2012/0266(COD)

COD - Ordinary legislative procedure (ex-codecision procedure)

Regulation

Amending Directive 2001/83/EC 1999/0134(COD)
Amending Regulation (EC) No 178/2002 2000/0286(COD)
Amending Regulation (EC) No 1223/2009 2008/0035(COD)
See also 2012/0267(COD)
Amended by 2020/0060(COD)
Amended by 2022/0417(COD)
Amended by 2023/0005(COD)
Amended by 2024/0021(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	WILLMOTT Dame Glenis (S&D)	16/10/2012
	MCGUINNESS Mairead (PPE) KRAHMER Holger (ALDE) RIVASI Michèle (Verts/ALE) YANNAKOUDAKIS Marina (ECR)

Former committee responsible

Former committee responsible	Former rapporteur	Appointed
ENVI Environment, Public Health and Food Safety	ROTH-BEHRENDT Dagmar (S&D)	16/10/2012

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	3526	07/03/2017
Employment, Social Policy, Health and Consumer Affairs	3323	19/06/2014
Employment, Social Policy, Health and Consumer Affairs	3351	01/12/2014
Employment, Social Policy, Health and Consumer Affairs	3280	09/12/2013
Employment, Social Policy, Health and Consumer Affairs	3475	16/06/2016
Employment, Social Policy, Health and Consumer Affairs	3206	06/12/2012

European Commission

Commission DG	Commissioner
Health and Food Safety	MIMICA Neven

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

Technical information

Technical information

Procedure	Information
Procedure reference	2012/0266(COD)
Procedure type	COD - Ordinary legislative procedure (ex-codecision procedure)
Nature of procedure	Legislation
Legislative instrument	Regulation
	Amending Directive 2001/83/EC 1999/0134(COD) Amending Regulation (EC) No 178/2002 2000/0286(COD) Amending Regulation (EC) No 1223/2009 2008/0035(COD) See also 2012/0267(COD) Amended by 2020/0060(COD) Amended by 2022/0417(COD) Amended by 2023/0005(COD) Amended by 2024/0021(COD)
Legal basis	Treaty on the Functioning of the EU TFEU 168-p4 Treaty on the Functioning of the EU TFEU 114-p1
Mandatory consultation of other institutions	European Economic and Social Committee European Committee of the Regions
Stage reached in procedure	Procedure completed
Committee dossier	ENVI/8/06745

Documentation gateway

Documentation gateway

European Parliament

Document type	Committee	Reference	Date
Committee draft report		PE507.972	12/04/2013
Amendments tabled in committee		PE510.536	26/04/2013
Amendments tabled in committee		PE510.767	14/05/2013
Amendments tabled in committee		PE510.766	14/05/2013
Amendments tabled in committee		PE510.765	14/05/2013
Amendments tabled in committee		PE510.741	14/05/2013
Amendments tabled in committee		PE510.666	17/05/2013
Committee opinion	EMPL	PE506.249	20/06/2013
Committee opinion	IMCO	PE507.987	08/08/2013
Committee report tabled for plenary, 1st reading/single reading		A7-0324/2013	09/10/2013
Text adopted by Parliament, partial vote at 1st reading/single reading		T7-0428/2013	22/10/2013
Text adopted by Parliament, 1st reading/single reading		T7-0266/2014	02/04/2014
Committee draft report		PE601.098	15/03/2017
Committee recommendation tabled for plenary, 2nd reading		A8-0068/2017	23/03/2017
Text adopted by Parliament, 2nd reading		T8-0107/2017	05/04/2017

Council of the EU

Document type	Reference	Date
Council statement on its position	06592/1/2017	27/02/2017
Council position	10728/4/2016	08/03/2017
Draft final act	00014/2017/LEX	05/04/2017

European Commission

Document type	Reference	Date
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
Legislative proposal	COM(2012)0542	26/09/2012
Commission response to text adopted in plenary	SP(2014)471	09/07/2014
Commission communication on Council's position	COM(2017)0129	09/03/2017
Follow-up document	SWD(2024)0076	22/03/2024

National parliaments

Document type	Parliament/Chamber	Reference	Date	Summary
Contribution	IT_SENATE	COM(2012)0542	25/10/2012

Other institutions and bodies

Institution/body	Document type	Reference	Date	Summary
EDPS	Document attached to the procedure	N7-0042/2014 OJ C 358 07.12.2013, p. 0010	08/02/2013
ESC	Economic and Social Committee: opinion, report	CES2185/2012	14/02/2013