4.1. Internal market rules regarding the free movement of goods
4.1.1. Industrial products covered by the new approach (CE-marking) in technical harmonisation
4.1.2. Foodstuffs
4.1.3. Chemical products
4.1.4. Other products
4.1.1. INTERNAL MARKET RULES – TECHNICAL HARMONISATION
(sectors harmonised according to the “New Approach” – CE-marking)
‘What is CE-marking?’
‘Which European product laws and standards, e.g. technical requirements, labelling and packaging rules, environmental rules, have to be applied for selling products in the European Union that are covered by the so-called new approach in technical harmonisation?
‘Where can we buy harmonised standards which we need for complying with the requirements of new approach directives?’
For an answer to these questions, look into the websites and publications presented below.
A/ Web pages with general information on European technical harmonisation and standardisation principles |
Information source 1: European Commission – Scadplus database (= summaries of EU legislation)
Website: http://ec.europa.eu/scadplus/
To find info in this website, follow the example.
Example: Which harmonised technical requirements apply to low voltage electrical equipment in the EU?
Step 1: login to the website of Scadplus (click on the link above)
Step 2: select ‘Index – T – Technical harmonisation – Electrical and electronic equipment and gas appliances – Low voltage electrical equipment‘ and find the title and summary of a relevant EU law (e.g. Dir. 73/23/EEC).
For consultation of full texts of EU laws: consult Eur-Lex (see below)
Information source 2: European Commission – Eur-Lex database (= full texts of EU legislation)
Website: http://eur-lex.europa.eu/en/index.htm
To find info in this website, follow the example.
Example: How to find the text of the Low Voltage Directive (= Dir. 73/23/EEC)?
Step 1: login to the website of Eur-Lex (click on the link above) and click on “Simple search”
Step 2: click on “Search by natural number”
Step 3: Enter the year “1973” and the number “23”, select “Directive” and click on “search”
Step 4: Click on “Bibliographic notice”
Step 5: Click on “Repealed by 32006L0095“
Step 6: Consult Directive 2006/95/EC (the new codified text of the Low Voltage Directive)
Information source 3: New Approach website (= references to laws and harmonised standards)
Website: http://www.newapproach.org
To find info in this website, follow the example.
Example: How to find the list of Harmonised Standards that are available for compliance with the Medical Devices Directive (= Dir. 73/23/EEC)?
Step 1: login to the New Approach website (click on the link above)
Step 2: click on ‘Directives and Standards’
Step 3.: move to the line with info about ‘93/42/EEC Medical devices: general”
Step 4: click on ‘References Harmonised Standards’
Step 5: select from the list relevant standards
Step 6: go to ‘Standards sales points’ and order the texts of harmonised standards from a national standardisation institute near to your location.
Information source 4: European Commission – DG Enterprise and Industry (= EU policy on new approach in technical harmonisation)
Website: http://ec.europa.eu/enterprise/index_en.htm
To find info in this website, follow the example.
Example: How to find a practical guide on the implementation of the Personal Protective Equipment Directive (= Dir. 89/686/EEC)?
Step 1: login to the website of DG Enterprise and Industry (click on the link above)
Step 2: select at the ‘Index A to Z’ the item ‘Mechanical Equipment’ followed by ‘Personal Protective Equipment’
Step 3.: click on ‘How to apply the Directive 89/686EEC?’
B/ General guide / publication |
“Guide to the Implementation of Directives Bases on New Approach and Global Approach”
http://ec.europa.eu/enterprise/newapproach/legislation/guide/index.htm
C/ “New Approach” directives and related European harmonised standards |
To become a harmonised standard, it must be accepted by the European Commission. The Commission harmonises the standard by publishing the title together with the directive in the Official Journal. Once adopted,
European Harmonised standards must be published by national members of CEN, CENELEC and ETSI and national standards must be withdrawn.
Whereas essential requirements are binding, standards are, as a rule, voluntary. Manufacturers do not have to follow harmonised standards to comply with product directives. They are free to choose any technical solution that will meet the essential requirements. However, products in conformity with harmonised standards are cobsidered to fulfil the essential requirements in the directive (presumption of conformity).
Following websites list harmonised standards for each sector covered by the new approach in technical harmonisation:
http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist.html
http://www.newapproach.org
Texts of European harmonised standards may be ordered from National Standardisation bodies which can be identified via following websites:
CEN (European Committee for Standardisation
Rue de Stassart, 36
B-1050 Brussels
Tel.: 32 2 550 08 11
Fax: 32 2 550 08 19
E-mail: infodesk@cenorm.be
http://www.cenorm.be
CEN national members
http://www.cenorm.be/cenorm/standards_drafts/index.asp
CENELEC (European Committee for Electrotechnical Standardisation)
Rue de Stassart, 35
B-1050 Brussels
Tel.: 32 2 519 68 71
Fax: 32 2 519 69 19
E-mail: general@cenelec.be
http://www.cenelec.org
CENELEC national members
http://www.cenelec.eu/Cenelec/CENELEC+in+action/Web+Store/Standards/default.htm
ETSI (European Telecommunications Standards Institute)
650, route des Lucioles
F-06921 Sophia Antipolis Cedex
Tel.: 33 4 92 94 42 00
Fax: 33 4 93 65 47 16
E-mail: infocentre@etsi.org
http://www.etsi.org
ETSI national members
http://portal.etsi.org/Portal_Common/home.asp
D/ Notified bodies |
Lists of notified bodies, including the identification number of a notified body as well as the tasks for which it has been notified, can be found in following web sites:
http://ec.europa.eu/enterprise/newapproach/legislation/nb/notified_bodies.htm
http://ec.europa.eu/enterprise/newapproach/nando/
E/ Product liability |
The EU's Directive on product liability can be consulted at:
http://eur-lex.europa.eu/Notice.do?val=115911:cs&lang=en&list=115911:cs,&pos=1&page=1&nbl=1&pgs=10&hwords=
F/ General product safety |
The EU’s General product safety directive can be found at:
http://eur-lex.europa.eu/Notice.do?val=272287:cs&lang=en&list=272287:cs,258366:cs,258142:cs,&pos=1&page=1&nbl=3&pgs=10&hwords=
G/ Agreements with third countries |
A list of Mutual Recognition Agreements (MRA) can be found at:
http://ec.europa.eu/enterprise/international/index_en.htm
H/ Quality Management Systems |
ISO (International Organisation for Standardisation)
1, rue de Varembé
Case postale 56
CH – 1211 Geneva 20
Tel.: 41 22 749 01 11
Fax: 41 22 733 34 30
E-mail: central@iso.ch
http://www.iso.ch
EOQ (European Organisation for Quality)
PO Box 5032
CH – 3001 Bern
Tel.: 41 31 320 67 20
Fax: 41 31 320 68 28
http://www.eoq.org
EOQ national members
http://www.eoq.org/WhatIsEOQ_FmosReps.html
EFQM (Euopean Foundation for Quality Management)
Brussels Represantation Office
Avenue des Pléiades 15
B-1200 Brussels
Tel.: 32 2 775 35 11
Fax: 32 2 775 35 35
E-mail: info@efqm.org
http://www.efqm.org
EFQM national members
http://www.efqm.org/Default.aspx?tabid=71
I) Accreditation of certification institutions |
Following institutions operate in this field:
European Co-operation for Accreditation
http://www.european-accreditation.org/default_flash.htm
International Accrediation Forum, Inc. (accreditation institutions for certiciation institutions)
http://www.iaf.nu
International Laboratory Accreditation Cooperation (accreditation institutions for inspection institutions and laboratories)
http://www.ilac.org
J) CE mark |
The CE mark may be downloaded in different electronic formats from the following site:
http://ec.europa.eu/enterprise/faq/ce-mark.htm
4.1.2. INTERNAL MARKET RULES - HYGIENE AND SAFETY OF FOODSTUFFS
‘Which European rules on foodstuffs relate to technical, labelling and packaging issues?
‘Where can companies consult guidance documents on HACCP?
‘Which labels are officially approved regarding the origin of foodstuffs, organic production, traditional specialties, etc.?
For an answer to these questions, look into the websites and publications presented below.
I. EUROPEAN FOODSTUFFS LEGISLATION |
Following web pages allow to identify laws in the field of foodstuffs legislation:
I.1. Summaries of EU foodstuff laws
Information source: European Commission - SCADPLUS Website: http://europa.eu/scadplus/ |
How to use this website?
Select “Index”
Select “F” and then “Foodstuffs” or “Food safety”
Result: the user will find titles and brief summaries of EU foodstuff laws
I.2. Full texts of EU foodstuff laws
Information source: European Commission - EUR-LEX |
How to use this website?
Step 1: Try to find titles and reference numbers of EU Directives, Regulations, Decisions, etc. via the “Scadplus” website (see I.1.).
Example: search Directive 200/13/EC
Step 2: Login to the website of Eur-Lex (click on the link above) and click on “Simple search”.
Step 3: Click on “Search by natural number”.
Step 4: Enter the year (“2000”) and the number (“13”), select “Directive” and click on “search”.
Step 4: Click on “Bibliographic notice”.
Step 5: Click on the most recent consolidated version of the Directive
I.3. EU policy in the field of food and feed safety
Information source: European Commission – DG Health and Consumer Protection |
This website contains a detailed description of topics regulated under EU foodstuffs and animal feed laws (e.g. comments, information about new legislation under preparation, contact points, etc).
More specific, following topics are presented:
- General Food Law Principles
Precautionary principle
Traceability
Responsibilities
Procedures
- Animal nutrition Labelling of feed materials
Feed hygiene
Feed additives
Approval & registration of
Establishments
Undesirable substances
Sampling and analysis methods
Official controls
Legislation list
- Labelling and nutrition Food labelling
Health and nutrition claims
Nutrition labelling
Mineral waters
Food supplements
Addition of vitamins & minerals
Dietetic foods
Foods for infants & young children
Foods for weight reduction
Foods for special medical purposes
Foods for sports people
Foods for diabetics
- Biotechnology Novel foods
GM food
GM feed
GM plants & seeds
Strategy for Europe
Authorisation
- Chemical safety Additives
Flavourings
Contaminants
Residues
Food contact materials
- Biological safety Food Hygiene
BSE / Scrapie
Animal by-products
Salmonella / Food-borne diseases
Microbiological criteria
Community reference laboratory
Irradiation
- Controls Food control
Feed control
Other topics on this website:
II. HACCP AND FAO / WHO FOOD STANDARDS |
Foodstuff producers are legally obliged to apply the HACCP principles. HACCP is a method that companies must apply in order to safeguard the quality of food products, based on two pillars: analysis of the dangers (HA = Hazard Analysis) and determination of points in the production process where these dangers are being controlled (Critical Control Points). HACCP knows 7 principles.
1. The possible dangers which can occur are determined. This means that as well the microbial dangers (decay of products) as well as pollution (chemical pollution, strange objects) are taken into consideration. |
2. The points in the production process where the dangers can be managed / controlled efficiently, have to be laid down as critical control points (CCPs). Example: a sterilisation process. |
3. For these critical points border limits (critical limits) are determined which need to be respected. Example: the minimum and maximum temperature and the period of the sterilisation process. |
4. On these CCPs, the danger is managed by measurements of the functioning of the installation (= a system to monitor control of the CCPs). |
5. On beforehand, corrective measures are laid down, which need to be applied if measurements / monitoring show derogations. |
6. The complete system needs to be controlled regularly for its efficiency and needs to be adapted regularly in order to follow the changes of the process or the product. |
7. All actions in the company need to be registered (= a documentation concerning all procedures and records appropriate to these principles and their application). |
Information source: Codex Alimentarius Website: http://www.codexalimentarius.net |
How to use this website?
1) Information about food hygiene, incl. HACCP
Select “Official Standards – Special Publications”
Select “Food Hygiene – Basic Texts (2003)”
Result: document “Recommended International Code of Practice General Principles of Food Hygiene”
2) Information about standards for producing certain foodstuffs
Select “Official Standards – Official Codex Standards”
III. SCIENTIFIC ADVICE ON FOOD SAFETY |
Information source: The European Food Safety Authority Website: http://www.efsa.europa.eu/ |
The European Food Safety Authority (EFSA) provides objective scientific advice on all matters with a direct or indirect impact on food and feed safety. EFSA is also consulted on nutrition in relation to Community legislation. EFSA is an agency of the European Community. EFSA was established by the European Parliament in 2002 following a series of food scares in the 1990s (BSE, dioxins….) which undermined consumer confidence in the safety of the food chain.
EFSA’s broad mandate allows it to take a comprehensive view of the food chain and provide a coherent scientific basis for policy and legislation. The scope of its responsibilities, however, does not extend to risk management decisions, proposing or adopting legislation or control—all of which remain the responsibilities of the institutions designated in the Treaty. EFSA has six main tasks:
- to provide independent scientific advice on food safety and related issues to be used as a basis for risk management decisions by appropriate EU entities;
- to advise on technical food issues that underpin policy development and legislation related to the food chain;
- to collect and analyze data on dietary, exposure and other information relevant to potential risks along the food chain;
- to identify and provide early warning for emerging risks;
- to support the European Commission in the case of crisis;
-to communicate to the public on all matters within its mandate.
IV. SPECIFIC LABELS FOR FOODSTUFFS |
IV.1. Geographical indications & designations of origin, certificates of specific character of foodstuffs
Products which correspond with certain requirements can receive following kinds of labels:
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1) PROTECTED GEOGRAPHICAL INDICATION (PGI)
2) PROTECTED DESIGNATION OF ORIGIN (PDO)
3) GUARANTEED TRADITIONAL SPECIALTY
Information source: European Commission – DG Agriculture Website: http://ec.europa.eu/agriculture/foodqual/quali1_en.htm |
1. GEOGRAPHICAL INDICATIONS AND DESIGNATIONS OF ORIGIN
The following legislation deals with this matter.
Council Regulation (EEC) No 2081/92 of 14 July 1992 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs
This Regulation does not apply to wine products or spirit drinks. The protection of geographical indications and designations of origin for wines is ruled through the following Regulations.
- Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine
- Commission Regulation (EC) No 753/2002 of 29 April 2002 laying down certain rules for applying Council Regulation (EC) No 1493/1999 as regards the description, designation, presentation and protection of certain wine sector products
2. GUARANTEED TRADITIONAL SPECIALTY
The following legislation deals with this matter:
Examples
1) Champagne (France)
Champagne is a sparkling wine produced by inducing the in-bottle secondary fermentation of wine to effect carbonation. It is produced exclusively within the Champagne region of France, from which it takes its name. While the term "champagne" is used by some makers of sparkling wine in other parts of the world, numerous countries limit the use of the term to only those wines that come from the Champagne appellation. In Europe, this principle is enshrined in the European Union by Protected Designation of Origin (PDO) status. Other countries, such as the United States, have recognized the exclusive nature of this name, yet maintain a legal structure that allows longtime domestic producers of sparkling wine to continue to use the term "Champagne" under specific circumstances.
2) Feta-cheese (Greece)
There are seven ''protected designation of origin'' regions for feta production: the Peloponnese, Thessaly, Epirus, mainland Greece, Macedonia, Thrace and the island of Lesbos.
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IV.2. “BIO” Label for organic farming
Products which correspond with certain requirements can receive following label:
Information source: European Commission – DG Agriculture |
The following legislation deals with this matter.
Council Regulation (EEC) No 2092/91 of 24 June 1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs
The full texts of these EU-Regulations can be consulted at following information source:
Eur-Lex: http://eur-lex.europa.eu/en/index.htm
4.1.3. INTERNAL MARKET RULES - CHEMICAL PRODUCTS
‘Where can our company find an overview of safety pictograms and risk and safety phrases that need to be put on the label of chemical products?
‘What are the requirements for packaging materials used for the packing of chemical products?’
‘Which ingredients are allowed in cosmetic products?’
For an answer to these questions, look into the websites and publications presented below.
1. Summaries of EU laws in the field of chemical products
Information source: European Commission - Scadplus Website: http://europa.eu/scadplus |
How to use this website?
Step 1: Select “Index”
Step 2: Select “C” and then “chemical products”
Result: the user will find titles and brief summaries of EU laws for various groups of chemical products
2. Full texts of EU laws
Information source: European Commission - EUR-LEX |
How to use this website?
Step 1: Try to find titles and reference numbers of EU Directives, Regulations, Decisions, etc. via the “Scadplus” website.
Step 2: Select “Legislation” in Eur-Lex
Step 3: Verify whether a consolidated version exists of the document that you want to find. A consolidated version of an EU Directive or Regulation means that this version consists of a text with all amendments to an original text integrated in one document.
How to proceed?
Select “Consolidated legislation” followed by “Chronological index”.
Select the appropriate year, e.g. “1967”.
Find a directive, e.g. 67/548, by scrolling down in the list till the document “1967L0548” can be selected. If it concerns a Regulation, the letter “R” will be in the middle of this codification number and a letter “D” in case of a Decision”.
Select “Preamble – consolidated provisions”
Finally, you may read this document and/or send it to your e-mail address.
Step 4: In case no consolidated version is available, the reader can find:
a) the original text of a Directive, Regulation or Decision via “Search by document number”. Put the year (e.g. “1967”) in the left box and the Document number (e.g. “548”) in the right box;
b) all amendments to a Directive, Regulation or Decision under “More info”.
3. EU policy in the field of chemical products
Information source: European Commission – DG Enterprise and industry |
Select at the ‘Index A to Z’ the item ‘Chemicals’.
Companies can consult here following web pages of DG Enterprise and Industry at the European Commission in order to find guidance documents on EU laws for specific groups of chemical products.
CHEMICALS |
http://ec.europa.eu/enterprise/chemicals/legislation/dangerous/index_en.htm
Specific information about the new EU chemicals legisaltion REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals)
http://ec.europa.eu/enterprise/reach/index_en.htm
http://ec.europa.eu/enterprise/chemicals/legislation/fertilizers/index_en.htm
3. Detergents
http://ec.europa.eu/enterprise/chemicals/legislation/detergents/index_en.htm
COSMETICS |
EU policy in the field of cosmetics:
http://ec.europa.eu/enterprise/cosmetics/index_en.htm
CosIng is a specific database with information on cosmetic ingredients contained in the Cosmetics Directive: http://ec.europa.eu/enterprise/cosmetics/cosing/
PHARMACEUTICALS |
EU policy in the field of pharmaceuticals
http://ec.europa.eu/enterprise/pharmaceuticals/index_en.htm
4. Classification and labelling of chemical products
Information source: EUROPEAN CHEMICALS BUREAU |
Manufacturers and wholesalers can consult this website in order to find out all following information about chemical products:
How to use this website?
Step 1: Select “ESIS” from the menu (ESIS = European Chemical Substances Information System)
Step 2: Select a chemical substance via its EINECS, ELINCS, NLP or CAS no.
or via its molecular formula or its substance name (e.g. “benzene”)
Step 3: consult the list of classification and labelling information that relates to this substance
This search results for the product “BENZENE” in following information.
1) Classification nrs. (EC or EINECS No., CAS No.);
EC no.: 200-753-7
CAS no.: 71-43-2
Substance name: Benzene
2) Indication of danger and symbol(s);
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3) Risk phrases (R-phrases);
R45: May cause cancer
R46: May cause heritable genetic damage
R11: Highly flammable
R36/38: Irritating to eyes and skin
R48/23/24/25: Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed
4) Safety phrases (S-phrases);
S53: Avoid exposure – obtain special instructions before use
S45: In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible)
Information source: Ellis Publications BV |
Ellis Publications updates every 6 months following CDs :
1) Dangerous Substances CD
2) Cosmetics CD
3) Euro Transport CD
Contents
1) DANGEROUS SUBSTANCES CD
a) the classification, packaging and labelling of dangerous substances and preparations;
b) restrictions on the marketing and use of certain dangerous substances and preparations;
c) major accident hazards of industrial activities (SEVESO) and the COMAH directive;
d) protection of workers from chemical agents;
e) import and export of chemical agents.
2) COSMETICS CD
This CD incorporates all EU legislation on the labelling and packaging of cosmetic products, including the consolidated text of Directive 76/768/EEC.
It contains a list of substances that cannot be included in the composition of cosmetic products plus lists of colourings, preservatives and UV filters that are permitted. An ingredient’s functions, mandatory restrictions, conditions of use and warnings can be easily retrieved by INCI, Ph. Eur., INN, IUPAC or chemical name, CAS or EINECS/ELINCS number. It also includes legislation on the testing of animals and information on the Scientific Committee.
3) EURO TRANSPORT CD
This module covers safety regulations for the transport of dangerous goods by road, rail, inland waterway and sea. It contains all current and proposed legislation with fully searchable tables and annexes. It also covers legislation on safety advisers and safety checks, Multilateral Agreements and details on Competent Authorities for the application of ADR.
4.1.4. INTERNAL MARKET RULES - OTHER PRODUCTS
‘Where can our company find an overview of product laws for goods not belonging to the sectors mentioned in previous sections?
For an answer to these questions, look into the websites and publications presented below.
Such goods concern: - motor vehicles
- textile products and footwear
- furniture
1. Summaries of EU laws
Information source: European Commission - Scadplus Website: http://europa.eu/scadplus |
How to use this website?
Example 1: EU laws on motor vehicles
Step 1: Select “Index”
Step 2: Select “T” and then “Technical harmonisation”
Step 3: Select “Harmonised Sectors – Previous Approach – Motor Vehicles
Result: the user will find titles and brief summaries of EU laws for various aspects of motor vehicles
Example 2: EU laws on textile products
Step 1: Select “Index”
Step 2: Select “T” and then “Technical harmonisation”
Step 3: Select “Harmonised Sectors – Previous Approach – Labelling and packaging – Non food product labelling – Textiles / Shoes
Result: the user will find titles and brief summaries of EU laws on labelling of textiles and shoes
2. Full texts of EU laws
Information source: European Commission - EUR-LEX |
How to use this website?
Step 1: Try to find titles and reference numbers of EU Directives, Regulations, Decisions, etc. via the “Scadplus” website (see I.1.).
Example: search Directive 200/13/EC
Step 2: Login to the website of Eur-Lex (click on the link above) and click on “Simple search”.
Step 3: Click on “Search by natural number”.
Step 4: Enter the year (“2000”) and the number (“13”), select “Directive” and click on “search”.
Step 4: Click on “Bibliographic notice”.
Step 5: Click on the most recent consolidated version of the Directive
3. EU policy in the field of various products
Information source: European Commission – DG Enterprise and Industry |
Select «Industry sectors ».
Companies can consult different web pages of DG Enterprise and Industry at the European Commission in order to find here references to EU laws and related guidance documents for specific products.
Examples:
1) Textile products: http://ec.europa.eu/enterprise/textile/doc_dir.htm
2) Footwear: http://ec.europa.eu/enterprise/footwear/intlmarket.htm
3) Furniture: http://ec.europa.eu/enterprise/furniture/intlmarket.htm
4) Motor Vehicles: http://ec.europa.eu/enterprise/automotive/directives/index.htm
Highly flammable
Toxic