New legal requirements for submission of product information to poisons centres in EU member states

Figures & data

Table 1. Overview of required information items (adapted from PART C of regulation (EU) no 2017/542 [5]).

Identification of the mixture and of the submitter
Product identifier	Complete trade name of the product (in case of group submission, all product identifiers shall be listed)
	Other names, synonyms
	Unique Formula Identifier(s) (UFI)
	Other identifiers (authorisation number, company product codes)
Contact details of submitter	Name
	Full address
	Telephone number
	E-mail address
Contact details for rapid access to additional product information (24 h/7 days). Only for limited submission.	Name
	Telephone number (24 h per day, 7 days per week)
	E-mail address
Classification of the mixture, label elements and toxicology
Classification of the mixture and label elements	Hazard class and category
	Hazard pictogram codes (according to Annex V to the CLP Regulation)
	Signal word
	Hazard statement codes, including supplemental hazard information codes (Annex III to the CLP Regulation)
	Precautionary statement codes (Annex IV to the CLP Regulation)
Toxicological information	Description of the toxicity of the mixture or its components (as required in section 11 of the Safety Data Sheet in accordance with Annex II to Regulation No 1907/2006)
Additional information on the mixture	Colour
	pH (where applicable)
	Physical state
	Packaging (type and size)
	Intended use (product categorisation code)
	Uses (consumer, professional, industrial)
Product identifiers of the mixture components
Product identifiers of the mixture components (substances and mixtures in mixtures where applicable)	Chemical/trade name of the components
	CAS number (where applicable)
	EC number (where applicable)
	UFI (where applicable)
Concentration and concentration ranges of the mixture components (substances and MIM)	Exact concentration or concentration range
Classification of mixture components (substances and MIM)	Hazard classification (where applicable)
	Additional identifiers (where applicable and relevant for health response)

Items requiring new (or more detailed) information as compared to the safety data sheet according to Annex II to REACH [6] are marked with grey background.

Table 2. Legislative text on concentration requirements (adapted from regulation (EU) no 2017/542 [5]).

Requirements on concentrations for hazardous components of major concern for emergency health response and preventative measures
When mixture components are classified in accordance with this Regulation for at least one of the hazard categories listed below, their concentration in a mixture shall be expressed as exact percentages, in descending order by mass or volume:  - Acute toxicity, Category 1, 2 or 3;  - Specific target organ toxicity - Single exposure, Category 1 or 2;  - Specific target organ toxicity - Repeated exposure, Category 1 or 2;  - Skin corrosion, category 1, 1A, 1B or 1C;  - Serious eye damage, Category 1; As an alternative to providing concentrations as exact percentages, a range of percentages may be submitted in accordance with [the table below].
Concentration range of the hazardous component contained in the mixture (%)	Maximum width of the concentration range to be used in the submission
≥25 to <100	5% units
≥10 to <25	3% units
≥1 to <10	1% units
≥0.1 to <1	0.3% units
>0 to <0.1	0.1% units
Requirements on concentrations for other hazardous components and components not classified as hazardous
The concentrations of the hazardous components in a mixture not classified for any of the hazard categories listed [above] and of the identified components not classified as hazardous shall be expressed, in accordance with [the table below], as ranges of percentages in descending order by mass or volume. As an alternative, exact percentages may be provided.
Concentration range of the component contained in the mixture (%)	Maximum width of the concentration range to be used in the submission
≥25 to <100	20% units
≥10 to <25	10% units
≥1 to <10	3% units
>0 to <1	1% units

Commission Regulation (EU) 2017/542 of 22 March 2017 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures by adding an Annex on harmonised information relating to emergency health response [Internet]; [cited 2017 Mar 29]. Available from: http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1490793693422&uri=CELEX:32017R0542

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Annex II to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Text with EEA relevance) [Internet]; [cited 2017 Mar 29]. Available from: http://eur-lex.europa.eu/legal-content/en/TXT/?qid=1450695527736&uri=CELEX:02006R1907-20151227

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