Workshop on the Implementation of detergents Regulation

Bucharest, September 21-22

The state of play in Romania in the area of detergents

Florentina DANILA ,

Councellor Directorate of Waste and Dangerous Chemicals, (RO) Tel. : 004/0213174070

e-mail: florentina.danila@mmediu.ro

Current legislation on detergents

COMMUNAUTAIRE ACQUIS LEGISLATION NATIONAL Legislatie Nationala Aquis comunitar Regulation (EC) No 648/2004 on Government Decision No. 658/2007 on detergents establishing implementation measures for Regulation No. 648 /2004 on detergents Ministerial Order No. 333/2008 for approving the list of authorized laboratory for detergents biodegradability tests in Romania (art. 8 (2) of the Regulation 648/2004/EC.

Ameding Regulation (EC) No 648/2004

Regulation (EC) No 551/2009

amending Regulation (EC) No 648/2004 on detergents, in order to adapt Annexes V and VI thereto (surfactant derogation)

Regulation (EC) No 907/2006 amending Regulation (EC) No 648/2004

on detergents, in order to adapt Annexes III and VII thereto

Regulation (EC) No 1336/2008 amending Regulation (EC) No 648/2004

in order to adapt it to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures
Regulation (EC) No 219/2009 adapting a number of instruments subject

to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny

Guidance on the implementation of the detergents legislation

CESIO

guideline which gives standardised declarations on biodegradability for use on Material Safety Datasheets (MSDS) to enable surfactant manufacturers to fulfil their responsibilities under Article 9 of Regulation (EC) No 648/2004 on the transmission of information for surfactants biodegradability as indicated by Article 9 of Regulation (EC) No 648/2004 to help industry with the implementation of the provisions on the biodegradability of surfactants and on the labelling of detergents under Regulation (EC) No 648/2004. This guideline was approved by the Commission and Member States at a meeting of the working group on detergents on 17 January 2005 No 648/2004

AISE/CESIO/ECOSOL/FECC guidelines

AISE has produced a guideline

" Read Across Rules " in the context of Annex III of Regulation (EC)

Old legislation on detergents

COMMUNAUTAIRE ACQUIS
Directive 86/94/EEC defined the BiAS method that is applicable to non-ionic containing 6-30 alkylene oxide (polyglycol) groups. Directive 82/243/EEC updated testing methods in 73/405/EEC adding the British "porous" test. It defined an anionic surfactant as one that responds to the MBAS method, so that important classes fell outside its scope. Directive82/242/EEC covering non-ionic surfactants closely parallels the 82/243/EEC in specifying an 80% pass level and introduced a derogation clause for temporary use of certain surfactants. Directive 73/405/EEC covering anionic (70% market share) surfactants already recognised the unreliability of primary biodegradability tests and establish that these surfactants must degrade by at least 80%.

OLD NATIONAL LEGISLATION

Government Decision No. 527/2001 determining the minimum degree of biodegradability of continuous surface agents in detergents, maintenance products and cleaning products Government Decision No. 745/1999 Rules approved labeling for cleaning, maintenance products and cleaning products

Brief Introduction to Regulation (EC) No 648/2004

establishes rules designed to achieve the free movement of detergents

and surfactants for detergents in the internal market while, at the same time, ensuring a high degree of protection of the environment and human health.
harmonizes the rules for the placing on the market of detergents and of

surfactants for detergents: - the biodegradability; - the restrictions ; - the additional labelling of detergents -the information that manufacturers must hold.
establishes rules for derogation for industrial or institutional detergents

 Regulation includes provisions relating to: Final requirements of biodegradability (both level and

methodologies used) for each surfactant (anionic, non-ionic, cationic and amphoteric) used in detergents.
Provisions relating to information provided to

consumers through labels and ingredients lists on websites.

Information must be held by manufacturers and

suppliers to request medical professionals and authorities.

Competent Authorities appointed for the enforcement of Regulation No. 648/2004

Regulation No. 648/2004 Government Decision No. 658/2007 on establishing implementation measures for Regulation No. 648 /2004 on detergents 1. Ministry of Environment-Coordination Authority

2. National Environment Protection Agency - Implementing Authority a) to receive, examine and evaluate the requests for derogation; b) to forward the result of their evaluation of the requests for derogation to the Advisory Scientific Inter-Ministerial Committee; c) to forward the results of evaluations of requests for derogations, endorsed under letter b) to the European Commission; d) to inform the Ministry of Environment the result of requests for derogation.

3. National Authority for Consumer Protection - Control Authority - Should the National Authority for Consumer Protection find that the detergents placed on the market do not comply with the Regulation provisions in point of biodegradability - may request any information from the manufacturer it must provide according to Article 9 of the Regulation and may take samples for testing products to the laboratories under Article 8 of the Regulation. If the National Authority for Consumer Protection found that detergents placed on the market do not meet the terms of biodegradability. a) notify the manufacturer on their obligation to withdraw the noncompliant products from the market; b) inform the National Environmental Protection Agency and the National Environmental Guard on the identified non-compliance. If it is found that detergents placed on the market do not comply with the Regulation on biodegradability are considered waste and managed under specific. 4. Environmental Guard - Control Authority

Duties of Manufacturers
Manufacturers shall hold at the disposal of the competent authorities

a technical file with the results for the test for ultimate biodegradability .
In the

case of surfactants that do not pass the ultimate biodegradability test, the technical file shall also contain the results of the primary biodegradability test and the complementary risk assessment.

For substances and preparations placed on the market manufacturers

must have documents to prove they comply with this regulation .

Manufacturers must provide the medical personnel to request a

product technical data sheet.

APPROVED LABORATORIES
Each Member State shall notify to the other Member States and to the Commission the list of approved laboratories, with their full name and address, that are competent and authorised to carry out the tests required by this Regulation The National Research & Development Institute for Industrial Ecology ECOIND
90-92 Panduri street, Sector 5, zip 050663Bucharest, ROMANIA +04.021/410.67.16 ; 410.03.7704.021/410.05.75; 412.00.42
ecoind@incdecoind.ro

Ministerial Order No. 333/2008 for approving the list of authorized laboratory fordetergents biodegradability tests in Romania (art. 8 (2) of the Regulation 648/2004/EC. ECOIND carry out tests according to Art. 8 para. (2) of Regulation (EC) no. 648/2004 and its annexes.

For a brief description of the provisions of European legislation can access:

Site of the European Commission - DG Enterprise:

http://ec.europa.eu/enterprise/sectors/chemicals/documents/specificchemicals/detergents/ - EU official languages for documents and reports, studies, points of contact, list of approved laboratories.
Site of the European Commission - DG Enterprise

http://ec.europa.eu/enterprise/cosmetics/html/cosm_inci_index.htm An inventory of common names for ingredients used in cosmetic products relevant to labeling detergent (International Nomenclature Cosmetic Ingredient).
Ministry of Environment

http://www.mmediu.ro/departament_mediu/substante_chimice/deterg enti.htm

Thank You!