MCCAA other related questions

FAQs related to Competition and Consumer Affairs. 

MCCAA- chemicals, biocides, cosmetics, detergents, fertilisers, plant protection products, type approvals, lifts, and standards and metrology institute

The information provided in the answers should serve only as guidance and does not have any legal force. For online live FAQs updates refer here

CHEMICALS

WHEN IS REACH REGISTRATION REQUIRED?

REACH registration with ECHA is required when a substance is manufactured or imported in volumes at or above 1 tonne per year.

WHAT IS TREQUIRED TO BE SHOWN ON LABELS OF HAZARDOUS CHEMICALS?

A substance or mixture classified as hazardous and contained in packaging shall bear a label including the following elements:

1. The name, full address and telephone number of the supplier(s)
2. The nominal quantity of the substance or mixture in the package made available to the public, unless this quantity is specified elsewhere on the package
3. Product identifiers as specified in Article 18 of the Regulation (EC) No. 1272/2008
4. Hazard pictograms, where applicable
5. Signal words, where applicable
6. Hazard statements, where applicable
7. Precautionary statements, where applicable
8. Supplemental information, where applicable

BIOCIDES

WHAT ARE THE NATIONAL RULES APPLICABLE FOR REGISTRATION OF BIOCIDAL PRODUCTS IN MALTA?

Biocidal products containing under review active substances must be notified in Malta before being made available on the market. The documents required for notification are as follows;

• Filled in and signed application form
• REACH and CLP compliant Safety data sheet (SDS) of the product
• REACH and CLP compliant SDSs of the individual hazardous substances found in section 3 of the product’s SDS
• Scanned or PDF copy of the product label (compliant with CLP and local language labelling requirements)
• Evidence that the active substance in the product originates from an approved supplier found on the Article 95 List. This evidence may be in the form of a recent invoice, a letter from the supplier or a self-declaration form
•  

HOW LONG DOES IT TAKE FOR A NOTIFICATIO APPLICATION TO BE PROCESSED AND WHAT ARE THE COSTS INVOLVED?

The time taken depends on the current workload at the CA and the quality of the documents submitted, but in general does not take longer than 1-2 weeks. A notification is currently associated with a fee of €25 and is valid for 2 years, and is renewable for €10.

WHAT LANGUAGES ARE REQUIRED ON THE LABELLING OF BIOCIDAL PRODUCTS IN MALTA?

The languages required depend on the product type to which the biocidal product belongs and to the category of users for which the biocidal product is intended. The language labelling requirements are set out in the Schedule of L.N. 348/2013 and are as follows;

WHICH ARE THE BIOCIDAL PRODUCTS NOTIFIED OR AUTHORISED FOR USE IN MALTA?

The database containing registered biocidal products can be found online on our website at [link to biocidal product database, currently at http://mccaa.org.mt/en/legislation-documents], or will be provided on request via email at [email protected].

IS MY PRODUCT A BIOCIDAL PRODUCT?

Biocidal products are used to control unwanted organisms that are harmful to human or animal health, or that cause damage to human activities. These harmful organisms include pests (e.g. insects, rats or mice) and microorganisms (e.g. moulds or bacteria).

Biocidal products include: insecticides (except those used for plant protection purposes which are regulated by Regulation (EU) No 1107/2009), insect repellents, disinfectants, preservatives for materials such as wood, plastics and fibres, anti-fouling paints for the protection of ship hulls (text from https://ec.europa.eu/health/biocides/policy_en).

It may not be immediately evident whether a product is a biocidal product or not. In cases of doubt, such as may be the case with borderline products such as medicines, cosmetics and cleaning chemicals, you can ask the Maltese Helpdesk directly at [email protected], whilst providing information such as the Safety Data Sheet of the product and a copy of its labelling.

I HAVE SEEN PRODUCTS ON THE MARKET INCORRECTLY LABELLED AND/OR IN A LANGUAGE WHICH IS NOT MALTESE OR ENGLISH. WHAT SHOULD I DO?

Products not registered with the MCCAA or not labelled as according to the labelling requirements can be reported to the Market Surveillance Directorate at the MCCAA, which can be contacted at +356 23952000.

IF A BIOCIDAL PRODUCT IS NOT AUTHORISED FOR USE IN MALTA, AM I ALLOWED TO BUY ONE OR TWO UNITS EXCLUSIVELY FOR PERSONAL USE ONLY?

According to Article 17 of the Biocidal Products Regulation, biocidal products ‘shall not be made available on the market or used unless authorised in accordance with [the] Regulation’. The Regulation makes no distinction between personal or non-personal use and thus a product cannot be used for personal use if it is not authorised as according to the BPR.

COSMETICS

WHAT IS REQUIRED TO BE PRESENTED ON A COSMETIC PRODUCT LABEL?

Cosmetic products labels must have the following:

1. The name or registered name and the full EU address of the responsible person. The country of origin shall be specified for imported cosmetic products.
2. The nominal content (by weight or by volume)
3. The durability sign (not required for products with a minimum durability of more than 30months)
4. Particular precautions
5. Batch number
6. Function of cosmetic products
7. A list of ingredients (the ingredients list should be written using the international nomenclature for cosmetic ingredients (INCI)

WHAT ARE THE ACCEPTED LANGUAGES TO BE USED ON COSMETIC PRODUCT LABELS?

Cosmetic product labels must be in either English and/or Maltese. Safety data sheets (SDSs) must be either in English or Maltese.

WHEN IS A COSMETIC PRODUCT REQUIRED TO BE NOTIFIED?

A cosmetic product needs to be notified through the cosmetic products notification portal (CPNP) when manufactured in an EU country for the first time and/or when imported from outside the EU to an EU country for the first time.

DETERGENTS

WHAT ARE THE ACCEPTED LANGUAGES TO BE USED ON DETERGENT PRODUCT LABELS?

Detergent product labels must be in either English and/or Maltese.

Safety data sheets (SDSs) must be in Maltese, English or Italian.

FERTILISERS

WHAT IS AN EC FERTILISER?

An EC fertiliser, which by definition is a material whose main function is to provide nutrient to the plants, is a fertiliser belonging to a type of fertilisers listed in Annex I of the Regulation (EC) No. 2003/2003 relating to fertilisers and complying with the conditions laid down in this Regulation. The designation “EC Fertiliser” shall not be used for a fertiliser which does not comply with this Regulation.

PLANT PROTECTION PRODUCTS

WHAT IS A PLANT PROTECTION PRODUCT?

A plant protection product is a 'pesticide' that protect crops or desirable or useful plants. They are primarily used in the agricultural sector but also in forestry, horticulture, amenity areas and in home gardens. They contain at least one active substance and have one of the following functions:

1. protect plants or plant products against pests/diseases, before or after harvest
2. influence the life processes of plants (such as substances influencing their growth, excluding nutrients)
3. preserve plant products
4. destroy or prevent growth of undesired plants or parts of plants

It may also contain other components including safeners and synergists. EU Member States authorise plant protection products on their territory and ensure compliance with EU rules.

WHAT IS AN ACTIVE SUBSTANCE?

An active substance is any chemical, plant extract, pheromone or micro-organism (including viruses), that has action against 'pests' or on plants, parts of plants or plant products. Before an active substance can be used within a plant protection product in the EU, it must be approved by the European Commission. Substances undergo an intensive evaluation and peer-review by Member States and the European Food Safety Authority before a decision can be made on approval.

HOW ARE PLANT PROTECTION PRODUCTS AND ACTIVE SUBSTANCES REGULATED?

Plant protection products and active substances are regulated by Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market in the EU and laying down the rules and procedures for authorization of products.

HOW ARE ACTIVE SUBSTANCE APPROVED?

The Commission evaluates every active substance for safety before it reaches the market in a product. Substances must be proven safe for people's health, including their residues in food and effects on animal health and the environment. Procedure for approval is as follows:

1. Application to an EU country called Rapporteur Member State (RMS);
2. RMS verifies if the application is admissible;
3. RMS prepares a draft assessment report;
4. EFSA issues its conclusions;
5. Standing Committee for Food Chain and Animal Health votes on approval or non-approval;
6. Adoption by the Commission;
7. Publication of a Regulation in the EU Official Journal.

Under the new EU rules, it takes 2.5 to 3.5 years from the date of admissibility of the application to the publication of a Regulation approving a new active substance.

TYPE APPROVALS

WHICH PRODUCTS DOES THE TYPE APPROVAL LEGISLATION APPLY TO?

The products which are regulated by type approval legislation are:

• Motor Vehicles
• Two- and Three-Wheel Vehicles and Quadricycles
• Tractors
• Engines installed in Non-Road Mobile Machinery

WHAT IS A TYPE APPROVAL CERTIFICATE?

A Type Approval Certificate is a document granted to the products mentioned above if they meet the applicable technical and safety requirements listed in either the EU Directives or Regulations or in the recognized UNECE Regulations which the EU has acceded to. A Type Approval Certificate is required before the mentioned products can be made available on the EU market. 

HOW DOES THE WHOLE VEHICLE TYPE APPROVAL SYSTEM WORK?

A manufacturer can obtain certification for a vehicle type in one EU country and then market it EU-wide without the need for further tests. This system significantly contributes to the completion of the single market in the automotive sector.

WHAT IS A TYPE APPROVAL AUTHORITY?

A Type Approval Authority is the authority of a Member State which issues Type Approval Certificates and handles all aspects related to the process of issuing such certificates.  A Type Approval Authority is also responsible for designating the Technical Service and for ensuring that the manufacturer meets his obligations regarding the conformity of production.

WHAT IS A TECHNICAL SERVICE?

A Technical Service is a body which is designated by the Type Approval Authority of a Member State as a testing laboratory to carry out tests, or as a conformity assessment body to carry out the initial assessment and other tests or inspections, on behalf of the Type Approval Authority.

WHEN SHALL THE EC TYPE APPROVAL MARK BE AFFIXED TO THE VEHICLE?

The manufacturer of a component or separate technical unit shall affix the EC type-approval mark to each component or unit which is manufactured in conformity with the approved type as required by the applicable legislation.  Where no EC type-approval mark is required, the manufacturer shall affix at least his trade name or trade mark, and the type number and/or an identification number.

WHAT IS A CERTIFICATE OF CONFORMITY?

A Certificate of Conformity is a document which is issued by the manufacturer and certifies that the vehicle complied with all regulatory acts at the time of its production. The manufacturer shall deliver a Certificate of Conformity to accompany each vehicle that is manufactured in conformity with the approved vehicle type.

WHERE CAN I FIND MORE INFORMATION ON TYPE APPROVALS?

More information on the applicable legal requirements for the following sectors can be found in the links below:

Motor Vehicles

https://ec.europa.eu/growth/sectors/automotive/legislation/motor-vehicles-trailers_en  

Two- and Three-Wheel Vehicles and Quadricycles

https://ec.europa.eu/growth/sectors/automotive/legislation/motor-vehicles-trailers_en  

Tractors

https://ec.europa.eu/growth/sectors/automotive/legislation/tractors_en

Engines installed in Non-Road Mobile Machinery

https://ec.europa.eu/growth/sectors/automotive/environment-protection/non-road-mobile-machinery_en#leg

LIFTS

IS IT OBLIGATORY TO REGISTER THE LIFT WITH THE MCCAA?

Yes, all lifts should be registered with the MCCAA as per LEGAL NOTICE 231 of 2007. http://www.justiceservices.gov.mt/DownloadDocument.aspx?app=lom&itemid=10799&l=1  

HOW CAN I CHECK IF THE LIFT IS REGISTERED WITH THE MCCAA OR NOT?

Registered lifts are listed online at http://www.mccaa.org.mt/en/registeredlifts. You may also call the MCCAA on 23952000 providing the residing address and the serial number indicated in the lift cabin.

HOW CAN WE REGISTER THE LIFT WITH MCCAA?

If the lift was installed and put into service before 1st July 2002, defined as per Legal notice 231 of 2007 as an ‘existing lift’, the responsible person/s/administrator shall register the lift with MCCAA.

If the lift was installed and put into service after 1st July 2002, defined as ‘New lift’, the installer is responsible to register the lift.

IS THERE A FEE APPLICABLE TO REGISTER A LIFT WITH MCCAA?

Yes, the fee is of €10 payable to MCCAA by cheque or by bank transfer (40019986609).

WILL THE MCCAA PROVIDE A REGISTRATION CERTIFICATE FOR THE LIFT WHEN IS REGISTERED?

Yes, once the application is processed and details are verified, a unique registration certificate for that particular lift is issued by MCCAA. The certificate will be sent by registered post to the address provided on the application. A list of approved ACABs (Authorised Conformity Assessment Body) is mailed together with the certificate.

WHAT IS AN ACAB?

An ACAB (Authorised Conformity Assessment Body) is a body designated according to the Method for Designating Conformity Assessment Body Regulations, 2003 to carry out thorough examinations and preventive inspections on existing and new lifts.

WHAT IS THE DIFFERENCE BETWEEN A PREVENTIVE AND THOROUGH EXAMINATION ON LIFTS?

Preventive inspection has to be carried out at least once a year. Thorough examination has to be carried out at least once every ten years. These inspections must be performed by an ACAB.

ONCE THE INSPECTION REPORT IS DONE, WHAT ARE THE NEXT STEPS?

A copy of the report shall be sent to the MCCAA. The original shall be kept in the lift’s safety file. An acknowledgement letter will be sent.

WHAT HAPPENS IF THE ACAB NOTICES THE NEED FOR REPAIRS OR MAINTENANCE DURING INSPECTION?

In this case the ACAB shall also indicate a time frame for the issue to be rectified. Once necessary repairs/maintenance is carried out, you need to notify the MCCAA that the repair/replacement works have been done.

HOW CAN I CHECK MY GAS REGULATOR?

The domestic gas supply in Malta is LPG; a mixture of Butane and Propane, and only regulators intended for LPG are to be used for domestic applications in Malta.

It is important that regulators used are compliant with the following information, which information should be found on the product:

On the product label:

• The standard EN16129
• The type of gas it is designed to operate with, in Malta LPG (liquid petroleum gas)

On the underside of the regulator:

• Manufacturing date
• Dimension of valves that it is designed to operate with, in Malta Ø 22mm

On the packaging or information leaflet:

• Lifetime of the product
• Instructions on how to operate the product

STANDARDS AND METROLOGY INSTITUTE

WHAT IS A STANDARD?

Standards are documents defining characteristics (for example, dimensions, safety aspects, performance requirements) of a product, process or service, in line with the technical/technological state-of-the art.

HOW ARE STANDARDS DEVELOPED?

Standards are developed by experts in technical committees. They represent the interested economic and social parties “stakeholders” (producers, services providers, suppliers, users, consumers, public authorities, scientist/professional institutions, educational authority etc.) and contribute to the detailed technical content of the standard. 

WHO PUBLISHES THE STANDARD?

The national standardization body (the MCCAA in case of Malta) has the responsibility to validate the standard and publishes it in accordance with internationally accepted procedures. It provides the infrastructure, procedures and project management for the standards development process.

WHAT IS THE DIFFERENCE BETWEEN AN EN STANDARD, AN ISO STANDARD AND A NATIONAL STANDARD?

A national standard is a standard that is developed and used only in a particular country (such as Malta).  A European standard (EN) is developed by the European Standardisation Organisations (CEN, CENELEC and ETSI) and adopted by all member states of the EU as national standards.  International standards are developed by the three international organizations for standardizations ISO, IEC and ITU and can be adopted as national standards by all countries.

WHO DEVELOPS STANDARDS?

A group of stakeholders/ experts are asked to give their input in a technical committee to produce/update a particular standard. Anyone with technical knowledge on the standard in question can volunteer to take part in the technical committee.

DOES MALTA PARTICIPATE IN DEVELOPMENT OF EUROPEAN AND INTERNATIONAL STANDARDS?

Malta can participate in the development of European and International Standards if there is enough interest to form a local technical committee that can contribute to the work of the respective European or International technical committee.  If no mirror technical committee is formed in Malta, interested parties may contact the Standardisation Directorate of the MCCAA to follow the development of the standard and can provide their feedback to the MCCAA.

ARE STANDARDS MANDATORY LIKE REGULATIONS?

No, standards are voluntary and they serve as guidelines. Standards become mandatory when they have been incorporated into a business contract or incorporated into a regulation.

WHAT IS THE PROCEDURE TO DEVELOP A NATIONAL STANDARD?

When interest is registered to develop a national standard, the MCCAA establishes a technical committee made up of experts in the relative technical field. Once consensus is reached within the committee, the draft standard becomes available to the public for commenting.  Comments received are evaluated and relevant changes are made and agreed upon by the technical committee to the Standard. The standard is then adopted and announced in the Government Gazette as a National Standard.

HOW CAN STANDARDS BE USED FOR CERTIFICATION OF PRODUCTS AND SERVICES?

Standards are often used by independent certification bodies to give written assurance (often in the form of a certificate) that the product, service or system in question meets specific requirements detailed in a particular standard.

DOES THE MCCAA OFFER CERTIFICATION SERVICES? WHAT ARE THESE?

Yes, the MCCAA offers certification against a number of standards/ regulations, mainly: Quality and Environmental Management Systems, Occupational Health and Safety Management System, Organic Farming, Certification of Motor Vehicle Repair, Certification of Language Tour Providers, Certification of Public Health Pests Management System, EMAS and EcoLabel.

HOW CAN AN ORGANISATION APPLY FOR A CERTIFICATION SERVICE?

An organisation interested in one of the certification services offered, may contact the Standardisation Directorate by sending an email to [email protected] to be guided on the application and certification process being requested.

IS THE MCCAA RECOGNISED TO OFFER CERTIFICATION SERVICES?

Yes, the MCCAA is internationally recognised by UKAS (one of the largest accreditation bodies in the world) as following best international practices in respect of certification services offered to Quality and Environmental Management Systems international standards.  UKAS carries out regular (at least yearly) checks on how certification services are being carried out.