Sustainability News- Edition #4

REGULATORY UPDATES

SUSTAINABILITY NEWS

Prepared by S Scruggs and L Sterne

FOCUS TOPIC:

REACH EDITION - PART 1

REGULATION

REGULATION (EC) NO. 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 16 DECEMBER 2008 ON THE CLASSIFICATION, LABELLING AND PACKAGING OF SUBSTANCES AND MIXTURES, AS AMENDED

REACH stands for Registration, Evaluation, Authorisation, and Restriction of Chemicals

REACH is an EU Regulation that was adopted to improve the protection of human health and the environment from the risks that chemicals may pose The REACH Regulation first entered into force on 1 June 2007

In principle, REACH applies to all chemical substances used by manufacturers, which include both industrial processes as well as items used in our day-to-day lives, for example in cleaning products, paints, and articles such as clothes, furniture, and electrical appliances

As such, the REACH Regulation impacts most companies across the EU in that it establishes procedures for collecting and assessing information and hazards of substances.

HOW IS REACH RELEVANT TO ECOBAT?

WHAT IS REACH?

REACH places a positive duty on companies to ensure compliance.

To comply with the REACH Regulation, companies must, (i) identify, and (ii) manage the risks linked to the substances they manufacture and market in the EU

Accordingly, companies must demonstrate how the substance can be safely used and must communicate the risk management measures to the users

It follows that companies need to register their substances whereafter the EU will evaluate selected substances and assess whether the risks of these substances can be managed effectively.

Authorities can ban or restrict the use of certain chemical substances if it is perceived that the risks posed by these substances are unmanageable

REGISTRATION, EVALUATION, AUTHORISATION, AND RESTRICTION OF CHEMICALS

HOW DOES REACH AFFECT OUR BUSINESS?

REACH places certain obligations on role players such as manufacturers, importers, downstream users, and companies established outside the EU In addition, it lays down provisions relating to substances and mixtures placed on the market. These substances or mixtures are determined by the Classification, Labelling, and Packaging Regulation EC No 1272/2008 (the CLP Regulation”)

The CLP Regulation requires manufacturers, importers, or downstream users of substances or mixtures to classify, label, and package their hazardous chemicals appropriately before placing them on the market The primary purpose of the CLP is to determine whether a substance or mixture of substances includes properties that fall within the ambit of a “hazardous classification” and, if so, to ensure that the classification and labelling of hazardous chemicals are harmonised to ensure adequate risk management throughout the EU.

As such, the CLP Regulation is used to inform various laws on the risk management of chemicals, including REACH.

PROPOSAL FOR LEAD TO BE ADDED TO THE AUTHORISATION LIST UNDER REACH

Considering the CLP Regulations, lead forms part of substances with a hazardous classification.

Articles 68 and 69 of REACH provide for the process of introducing a new restriction or amending a current one Proposals for such restrictions can be prepared by Member States or by the European Chemicals Agency (“ECHA”) at the request of the Commission.

The proposal, in the form of a dossier, must demonstrate that there is a risk to human health or the environment that needs to be addressed at an EU-wide level

Following, interested parties will have an opportunity to comment during different stages of public consultation within the process and ECHA Committees and provide opinions on proposed restrictions before a final decision on whether to include the substance in Annex XVII or not is taken by the European Commission, in consultation with Member States.

On 27 June 2018, lead was included in the Candidate List of Substances of Very High Concern (“SVHC”) for authorisation for being toxic to reproduction

In April 2023, the ECHA recommended that lead be added to the Authorisation List (“REACH Annex XIV”) based on prioritization, which was supported by the opinion of the Member State Committee.

The European Commission and the Member States must now enter into discussions regarding ongoing regulatory activities for lead to ensure adequate and efficient risk management measures are in place If the European Commission decides to include lead in the Authorisation List, its use and placing on the market will be prohibited unless the company receives authorisation from the Commission to do so.

Notwithstanding the above, our focus in this edition will be on the requirements for Classification, Labeling, and Packaging under the CLP. In our next edition, we consider the requirements for SDS’ and more on the roles and duties of Manufacturers and Importers under REACH

CLASSIFICATION, LABELLING AND PACKAGING

CLP: PURPOSE AND SCOPE

The purpose of the CLP is to ensure the protection of human health and the environment as well as the free movement of substances, mixtures, and articles

The CLP sets out to achieve the above objective by harmonising the criteria for classifying substances and mixtures and providing rules on labelling and packaging for hazardous substances and mixtures

In addition, the CLP places an obligation on manufacturers, importers, and downstream users to classify substances and mixtures placed on the market and to communicate the risks associated with hazardous substances to other actors in the supply chain and to consumers

CLP: CLASSIFICATION -

LEAD

In terms of the CLP, a substance must be self-classified when it has no harmonised classification in Annex VI to CLP and it presents hazardous properties.

For a substance that already has a harmonised classification (an entry in Annex VI to CLP), the harmonised hazard classification is legally binding for the hazard classes and differentiations covered in the entry, which is the case with Lead being included under EC No 231-100-4/CAS 7439-92-1

CLP: LABELLING REQUIREMENTS

As mentioned above, manufacturers, importers, downstream users, and distributors must communicate risks associated with substances with a hazard classification to other actors in the supply chain and to consumers

This is done by labelling the substance or mixture as per CLP before placing it on the market

The requirements for labelling are set out under Title III in Chapter 1, Article 17 - 33 of the CLP, whereas specific packaging requirements are found under Title IV, Article 35.

In addition, specific requirements are set out regarding substances that fulfill the criteria as set out in Annex I, which is usually subject to the harmonised classification and labeling as per Article 37 This includes substances with reproductive toxicity properties and, therefore, includes lead Below is a quick reference

QUICK REFERENCE TABLE FOR LABELLING AND PACKAGING

General Rules:

Label to be written in the official language(s) of the Member State where supplied;

DEFINING “EXPOSED POPULATION“

Content of Label

Location of info on Label

Updating info on Label

Application of Labels

Packaging

Name, address and contact number of supplier; Nominal quantity of substance in package available (unless specified elsewhere);

Product identifiers - See Art 18;

Hazardous Pictograms - See Art 19;

Single Word Descriptions - See Art 20 read with Part 2 - 5 of Annex 1;

Hazard and Precautionary Statements - See Art 21 and Art 22 read with Part 25 of Annex I and Parts 2 and 3 of Annex VI;

Supplemental Information - See Art 25 read with sections 1 1 and 1 2 of Annexure II as well as Part 3 of Annex VI

The hazard pictograms, signal word, hazard statements and precautionary statements shall be located together on the label.

Groups of hazard statements and groups of precautionary statements referred to in paragraph 2 shall be located together on the label by language. The supplemental information shall be placed in the information section referred to in Art 25, and shall be located with the other label elements specified in Art 17

The supplier must ensure that the label is updated following any change to the classification and labeling of that substance or mixture, where the new hazard is more severe, or where new supplemental labeling elements are required under Art 25, taking into account the nature of the change as regards the protection of human health and the environment

The supplier must ensure that all labels are updated within 18 months.

Labels shall be firmly affixed to one or more surfaces of the packaging containing the substance or mixture and shall be readable horizontally when the package is set down normally

The colour and presentation of any label shall be such that the hazard pictogram stands out clearly

The label elements shall be clearly and indelibly marked The shape, colour and the size of a hazard pictogram as well as the dimensions of the label shall be as set out in section 1 2 1 of Annex I

General Packing requirements for hazardous substances:

Packaging must prevent the spill of the substance; Material used for the packaging must not be susceptible to damage by the contents; Packaging and fastenings must be constructed by materials that will not allow it to loosen or break during normal stresses and strains of handling; Packaging fitted with replaceable fastening devises must be designed so that it can be refastened repeatedly without alowing the contents to escape or spill Where the packaging containes a substance that meet the requirements of section 3 2 1 if Abbex II it must bear a tactile warning of danger sign in accordance with section 3 2 2 of Annex II