Commission Regulation amending Regulation (EC) No. 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging (CLP) of substances and mixtures added an Annex on harmonised information relating to emergency health response. In this article, Caroline Raine reviews the key changes.

Introduction

Following consultation with a number of stakeholders, the Commission identified a number of key issues:

  • a lack of consistency in the interpretation of the legislation across Europe

  • the likelihood of a business having to make multiple submissions, adding unfair cost and a significant burden on industry

  • in up to 40% of cases, the poison centre was providing advice on the wrong product, risking health and causing unnecessary hospital submissions.

Annex VIII to CLP aims to overcome these issues by harmonising poison centre registration across Member States and determining new methods for identifying and tracking registered products.

General requirements

The draft regulation outlines the general requirements for importers and downstream users who place mixtures on the market. Depending upon the use of the mixture, the deadline varies. Those placed on the market for:

  • consumer use must comply from 1 Jan 2020

  • professional use must comply from 1 Jan 2021

  • industrial use must comply from 1 Jan 2024.

Those importers and downstream users who have previously submitted information in accordance with Article 45 are not required to comply with this regulation until 1 January 2025.

The purpose, definition and scope are then laid out, and it is stated that the regulation requirements shall not apply to mixtures classified only as gases under pressure or explosives (unstable explosives and Divisions 1.1 to 1.6). An option to provide limited submission for industrial use only is laid out, and if this option is taken, a telephone number for rapid access to additional product information must be provided. This phone number must be accessible 24 hours per day, 7 days per week.

The following definitions for use are given as:

(1) ‘Mixture for industrial use’ means a mixture destined for use at industrial sites;

(2) ‘Mixture for consumer use’ means a mixture destined for use by consumers;

(3) ‘Mixture for professional use’ means a mixture destined for use by professional users but not at industrial sites.

Unique formula identifier

A Unique Formula Identifier (UFI) will be required on all packaging to make product identification quicker and easier once it is registered with the poison centre. UFI’s will be managed by the European Commission, which will bear the cost of allocating and maintaining this database. However, the cost to altering packaging to show these codes will be on the organisation that places the product on the market.

Product categorisation code

The intended use of the mixture shall be defined using a Product Categorisation Code (PCC), a harmonised product categorisation system will be provided by the agency.

Protecting intellectual property

To protect intellectual property, it will be permissible to use generic terms for components of mixtures — assuming they are not classified as hazardous by their physical or health effects — and are no more than 10% of the mixture. These include terms such as “fragrances” or “colouring agents”, and are accepted assuming compliance with the stipulations in Article 24 of CLP: proving that an International Union of Pure and Applied Chemistry (IUPAC) name would commercially harm the business, particularly its intellectual property.

Mixture components

The new regulation will require that substances or mixtures in mixture (MIM) that meet the following criteria must be declared in the submission. They are classified as hazardous (on the basis of their health or physical effects) which are:

  • present in concentrations equal or higher than 0.1%

  • identified even if in concentrations lower than 0.1%.

In addition, mixture components that are not classified as hazardous (on the basis of their health or physical effects) which are identified and present in concentrations equal to or greater than 1% must also be declared.

There are a number of hazard categories which will require the concentration to be submitted as exact percentage, in descending order by mass or volume. These hazard categories include:

  • 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.

The regulations allow for a range of percentages to be acceptable in the submissions. The following tables are taken from the draft regulation.

Concentration Ranges Applicable to Hazardous Components of Major Concern for Emergency Health Response (substances or MIM)

Concentration range of the hazardous component contained in the mixture (%)

Maximum width of the concentration range to be used in the submission

≥ 25 – < 100

5% units

≥ 10 – < 25

3% units

≥ 1 – < 10

1% units

≥ 0.1 – < 1

0.3% units

>0 – < 0.1

0.1% units

Concentration Ranges Applicable to other Hazardous Components and Non-hazardous Components (substances or mixtures in mixture MIM)

Concentration range of the component contained in the mixture (%)

Maximum width of the concentration range to be used in the submission

≥ 25 – < 100

20% units

≥ 10 – < 25

10% units

≥ 1 – < 10

3% units

>0 – < 1

1% units

Submission requirements

There is a wide range of submission formats used across Member States, requiring submissions in several formats and adding additional cost to industry.

All mixtures, must be registered before being placed on the market. Information on the health or physical effects must be provided in the official language(s) of the Member State(s) where the mixture is placed on the market (unless a Member State allows another language as an alternative). Submission updates are required when there is a change to the mixture or if new toxicological information on its hazardous properties becomes available.

There is also a provision for group submissions to be permissible where all grouped mixtures have the same hazards and whose constituents fall within the same concentration levels. This is anticipated to significantly reduce the volume of individual submissions and the burden to industry, particularly for products of a very similar nature that have a variety of trade names within a single market.

Information contained in a submission

The following information will be required in a submission.

  • Product identifier of the mixture:

    • trade name, or names of the mixture, brand name, product and variant names, any other names

    • the UFI(s)

    • other identifiers (registration number, authorisation number and company product codes).

  • Details of the submitter:

    • name

    • address

    • telephone number

    • VAT number

    • email address.

  • A 24/7 hour phone number if limited submission for industrial use is undertaken.

  • Classification of the mixture:

    • the hazard class and category of the mixture for health and physical hazards.

  • Label elements:

    • hazard pictograms

    • signal words

    • hazard statements (including supplemental hazard information)

    • precautionary statements.

  • Toxicological information:

    • description of the toxicity of the mixture or its components (as specified in s.11 of the Safety Data Sheet (SDS).

  • Additional information:

    • the type(s) and size(s) of the packaging

    • the colour and the physical state

    • the pH of the mixture

    • product categorisation

    • use (consumer, professional and industrial).

Conclusions

Changes are coming with regards to the harmonised format for notifying hazardous mixtures to Poison Centres. Make sure you keep up to date and don’t miss the deadlines. Our Poison Centre topic can also provide more information and detail.

Last reviewed 31 May 2019