SIST EN 15178:2008

Elements for the identification of products in emergency enquiries

This European Standard specifies requirements for an area on the packaging - the product identification field - marked by a symbol, where clear product identification element(s) is (are) present. This European Standard applies to products that are the subject of emergency enquiries to the poison information centres.
This European Standard does not apply to medicinal products (human and veterinary drugs) (see [2], [3]) and medical devices (see [4], [5]), as information requirements are already covered.

Elemente zur Produktidentifikation bei Notfallanfragen

Diese Europäische Norm legt Anforderungen für eine Fläche auf der Verpackung fest  das Produkt¬identifikationsfeld , das durch ein Symbol gekennzeichnet ist und in dem (ein) eindeutige(s) Element(e) zur Produktidentifikation vorhanden ist (sind). Diese Norm gilt für Produkte, die Gegenstand von Notfallanfragen bei den Giftinformationszentren sind.
Da Anforderungen an Informationen bereits abgedeckt sind, gilt diese Norm nicht für Arzneimittel (Medikamente für Menschen und Tiere) (siehe [2], [3]) und Medizinprodukte (siehe [4], [5]).

Eléments pour l'identification des produits lors des appels d'urgence

Le présent projet de norme spécifie les exigences relatives aux  éléments d'identification de produits qui font l'objet d'appels d'urgence aux centres anti-poisons et traite également de la conception de la zone d'identification du produit.

Embalaža - Elementi za prepoznavanje proizvodov (nevarnih preparatov) v nujnih primerih s pomočjo označb

General Information

• Status: Published
• Publication Date: 07-Oct-2008
• ICS: 01.080.10 - Public information symbols. Signs. Plates. Labels
• ICS: 13.300 - Protection against dangerous goods
• ICS: 55.020 - Packaging and distribution of goods in general
• Technical Committee: EPO - Packaging - sales and grouped
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 18-Sep-2008
• Due Date: 23-Nov-2008
• Completion Date: 08-Oct-2008
• Ref Project: EN 15178:2007 - Elements for the identification of products in emergency enquiries

Overview - EN 15178:2007 (CEN)

EN 15178:2007 specifies requirements for a product identification field on packaging to support emergency enquiries made to poison information centres. The standard defines a marked area (identified by a graphic symbol) where clear product identification element(s) are present so that, if packaging is available after an accident, callers and professionals can rapidly and unambiguously identify the product and its formulation. The standard excludes human/veterinary medicinal products and medical devices, whose labelling is covered elsewhere.

Key topics and technical requirements

• Product identification field: A combination of a graphic symbol and one or more identification elements placed on packaging (preferably on primary packaging).
• Graphic symbol: The standard mandates a recognizable “product information” symbol (see ISO 7000). The letter “i” in the symbol must be at least the same font size as the identification text.
• Identification elements: At least one item sufficient for unique product/formulation identification, e.g.:
  • clear product/trade name (long names may be abbreviated)
  • article number
  • registration number
  • authorization number
• Placement and legibility: The symbol and identification elements must be legible and indelible. The field should be adjacent to the bar code when available and the responsible party’s address should be nearby where possible.
• Change management: Identification must be updated if formulation changes affect physico‑chemical or toxicological properties (Annex A gives criteria such as classification changes or defined concentration thresholds).
• Data format recommendation: Use the first 128 ASCII characters where practical to ease phonetic transfer and electronic processing.
• Durability: The identification field must remain recognizable after opening the package in the normal way.

Applications and who uses it

• Poison information centres: Faster, more accurate product identification to provide treatment and safety advice after exposure incidents.
• Manufacturers and brand owners: Implement consistent labelling to comply with EN 15178 and improve consumer safety response.
• Packaging designers and regulatory affairs teams: Integrate the product identification field into label and packaging layout, keeping proximity to bar codes and company address.
• Emergency responders and healthcare professionals: Benefit from clearer product identification in incident triage and clinical decision-making.

Related standards and references

• EN 1556:1998 - Bar coding terminology (related to bar code placement)
• ISO 7000 - Graphical symbols for use on equipment (graphic symbol reference)
• EU directives referenced in EN 15178 (for classification and exclusions), e.g. directives on medicinal products and dangerous substances/preparations

EN 15178:2007 supports safer, more effective emergency response by standardizing how products are identified on packaging, improving information flow between consumers, manufacturers and poison information centres.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Elemente zur Produktidentifikation bei NotfallanfragenEléments pour l'identification des produits lors des appels d'urgenceElements for the identification of products in emergency enquiries55.020Pakiranje in distribucija blaga na splošnoPackaging and distribution of goods in general13.300Varstvo pred nevarnimi izdelkiProtection against dangerous goods01.080.10Simboli za javne informacijePublic information symbolsICS:Ta slovenski standard je istoveten z:EN 15178:2007SIST EN 15178:2008en,fr,de01-november-2008SIST EN 15178:2008SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 15178August 2007ICS 01.080.10; 13.200 English VersionElements for the identification of products in emergencyenquiriesEléments pour l'identification des produits lors des appelsd'urgenceElemente zur Produktidentifikation bei NotfallanfragenThis European Standard was approved by CEN on 13 July 2007.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2007 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 15178:2007: ESIST EN 15178:2008

Rationale.7 A.1 General.7 A.2 Dangerous preparations/substances.7 A.3 Other preparations (not classified as dangerous).7 A.4 Cosmetic products.7 Annex B (informative)
Examples for the arrangement of the product identification field in relation to the bar code and company address.9 Bibliography.11
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