Control of Detergents on the Greek market

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Control of Detergents on the Greek market

• TAIEX SEMINAR
• September 21st 22nd 2009
• Bucharest -Romania
• Presented by Sophia Antoniadou PhD chemist
• General Chemical State Laboratory
• Division of Raw materials Industrial products
• Athens Greece

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Legislative framework

• Regulation (EC) 648/2004, as amended.
• in force since 08.10.2005
• amendments Reg. (EC) 907/2006, 551/2009
• (replacement of Annexes III and VII, V and VI)
• articles 8, 10 and 18,
• mandate the member-states
• to lay down provisions for the
• enforcement of the Regulation.

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Legislative framework (continue)

• article 8 mandates the member-states
• to appoint
• the Competent Authority responsible for the
  management of the Regulation
• and
• the approved laboratories, for the performance of
  the tests required by the Regulation, certified
  according to ISO 17025 or GLP Good Laboratory
  Practice

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Legislative framework (continue)

• article 10 mandates the member-states to apply
• all necessary control measures to detergents
  placed on the market, to ensure compliance of the
  product with the provisions of the Regulation
• article18 mandates the member-states to apply
• sanctions in case of infringements .

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Legislative framework (continue)

• Pursuant to the provisions of these articles,
• in Greece a Ministerial Decision is adopted
  arranging the following
• national Competent Authority
• labelling of the products in native language
• measures for the control of the market
• fees , penalties and sanctions
• entry into force and repealed legislation

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Measures for the control of the market

• In order to apply the most appropriate measures,
  the following points were considered
• what kind of enterprises are operating in our
  country
• the kind and the origin of products circulated in
  the market
• the environmental parameters
• the geographical parameters

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(continue)Measures for the control of the market

• The facts are the following
• majority of the enterprises medium and small
  
• (national international of large size lt15)
• all kinds of products
• origin either EU or third countries
• (mainly from Italy, Spain, France, Germany,UK as
  well as China, Turkey, India, Israel etc.)
• almost 50.000 km of coastline in the eastern part
  of Mediterranean Sea
• Southeastern external border of EU

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(continue)Measures for the control of the market

• Control measures shall be
• easy fast to apply
• effective
• personnel equipment saving
• oriented
• 1st to check relevant documents
• 2nd to inspect
• 3rd to laboratory analysis

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((continue)Measures for the control of the
market

• Check of the data
• for the surfactant and/or the product
• 1. biodegradability of the surfactant(s)
• 2. composition and
• physicochemical parameters
• 3. classification and labelling

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(continue)Measures for the control of the market

• Other measures
• 4. Registration
• in the Registry of Cleaning Products
• 5. Inspections
• at production / packaging / storage /
  distribution premises and retailers
• 6. Sampling of products from the market
• and performance of full scale laboratory
  analysis.

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Check of the biodegradability of surfactants

• Check in the MSDS of the surfactant
• point 12 ECOLOGICAL INFORMATION
• there shall be mentioned
• the result of at least one biodegradability test
  according to the methods of Annex III of the
  Regulation
• example of wording
• threshold values for OECD 301D method are
  reached or
• ultimate biodegradability gt 60 , CO2
  liberation
• meaning by
• OECD 301D, the method of Dir. 67/548 Annex V.C.
  4-E
• OECD 301B, the method of Dir. 67/548 Annex V.C.
  4-C

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(continue) Check of the biodegradability of
surfactants

• Check in the MSDS of the surfactant
• point 16 OTHER INFORMATION
• shall mention
• The surfactant(s) contained in this preparation
  complies (comply) with the biodegradability
  criteria as laid down in Regulation (EC) 648/2004
  on detergents. Data to support this assertion are
  held at the disposal of the competent authorities
  of the Member-States and will be made available
  to them, at their direct request or at the
  request of a detergent manufacturer.

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(continue) Check of the biodegradability
of surfactants

• In case that no data are available or
  verification of the data is required
• we as Competent Authority- contact by written
  procedure (e-mail, letter etc.) the producer of
  the surfactant and request for additional
  information, i.e.
• valid data which prove that the surfactant
  fulfills the criteria of Annex III of the
  Regulation
• and / or
• submission of the corresponding test report.

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(continue)Check of the biodegradability of
products

• If there exists an MSDS of the product and the
  product contains surfactants
• check
• point 12 ECOLOGICAL INFORMATION or
• point 16 OTHER INFORMATION
• and follow the steps previously mentioned

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Check of the composition and physicochemical
properties of the product

• Crosscheck in the MSDS of the product
• (if there exists one)
• the coherence of the following
• Point 2 HAZARD IDENTIFICATION
• Point 3 COMPOSITION / INFORMATION ON
  INGREDIENTS
• Point 9 PHYSICAL AND CHEMICAL PROPERTIES
• Point 15 REGULATORY INFORMATION

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Check of the composition and physicochemical
properties of the product

• Why ? Because
• point 2 presents the hazard of the product,
• i.e. whether it is classified or not as
  dangerous.
• (see for details Reg. (EC)1907/2006 Annex II
  point 2)
• point 3 mentions substances presenting health
  or environmental hazard within the meaning of
  Directive 99/45/EC
• (see for details Reg. (EC)1907/2006 Annex II
  point 3)
• point 9 focuses on the pH, the flash point
  etc.
• (see for details Reg. (EC)1907/2006 Annex II
  point 9)
• point 15 presents the labelling of the
  product
• (see for details Reg. (EC)1907/2006Annex II
  point 15)

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Check of the classification and labeling
of the product

• Based on
• the exact w/w composition of the product
• the physicochemical parameters
• and
• the classification and labelling rules
• of Directives 67/548/EEC and 99/45/EC
• conclude on
• the classification and
• the label of the product.

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Registry of cleaning products

• What is the Registry ?
• It is a catalogue of all the cleaning products
  circulated into the Greek market and fulfilling
  the provisions of the Regulation.

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(continue)Registry of cleaning products

• Which is the aim of the Registry ?
• 1st
• support of the manufacturers
• by consultation during registration
• through precautionary check of the data for the
  products, aiming to the compliance with the
  Legislation, prior to the product circulation in
  the market.

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(continue)Registry of cleaning products

• Which is the aim of the Registry ?
• 2nd
• support of the Authorities for
• market surveillance
• external border controls

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(continue)Registry of cleaning products

• Which are the data to submit ?
• - commercial data
• - chemical data
• - other relevant data
• Confidentiality is legally binding
• to be kept, where appropriate

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(continue)Registry of cleaning products

• What is done with these data ?
• the coherence of all the data is checked
• and based on them,
• it is checked the products compliance
• (composition, biodegradability, label)
• with the provisions of the Legislation
• (Reg. 648/2004, dir. 99/45 and 67/548).

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INSPECTIONS at production / packagingstorage
/ distribution premises and retailers

• Inspections are performed under
• annual routine inspection programme
• other special reasons

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(continue)INSPECTIONS at production /
packagingstorage / distribution premises and
retailers

• Tools employed
• Specialized inspection documents
• (i.e. letters for the announcement of
  inspection,
• inspection forms,
• model forms for the results of the
  inspection,
• calls for explanations in case of
  infringements etc.)
• Data from the Registry of Cleaning Products
• Relevant Legislation ISO 17020
• (i.e. Reg.(EC) 648/2004, Dir. 99/45 and 67/548).

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Sampling of products from the market

• During surveillance activities
• of the market,
• samples of products are taken and
• submitted to laboratory analysis.

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(continue) Sampling of products from the market

• The results of the analysis are used to verify
  whether the product (composition,
  biodegradability, label)
• complies with the provisions of the Regulation
  and
• the data declared to the Registry are
  consistent with the results.

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Controls at the Customsfor conformity with the
Regulation

• During imports of surfactants
• and/or cleaning products from third countries,
• Customs Authorities check the coherence of
• The documents shipping documents, invoice,
  import declaration
• The product, its label and MSDS,
• as presented at import.
• In case of non-conformity
• the products are recalled or withdrawn.

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Va multumesc foarte multThank you for your
attention

• Sophia Antoniadou PhD Chemist
• E-mail gxk-industrial_at_ath.forthnet.gr