Disposal at sea is regulated through the following international and regional instruments:

  • The 1972 Convention on the Prevention of Marine Pollution by Dumping of Wastes and Other Matter known as the London Convention;
  • The 1996 Protocol to the London Convention known as the London Protocol;
  • The 1976 Convention for the Protection of the Mediterranean Sea Against Pollution known as the Barcelona Convention, amended in 1995; and
  • The 1976 Protocol for the Prevention and Elimination of Pollution of the Mediterranean Sea by Dumping from Ships and Aircraft or Incineration at Sea known as the Dumping Protocol .
  • The 1995 amendments to The 1976 Protocol for the Prevention and Elimination of Pollution of the Mediterranean Sea by Dumping from Ships and Aircraft or Incineration at Sea known as the Dumping Protocol

In Malta, disposal of waste at sea can only take place at the spoil ground located 35O 55.1’ N, 014O 34’E (outside the Grand Harbour- figure below), and such an activity is regulated by ERA through the Waste Consignment Note Procedure. Only disposal of certain wastes is allowed, and this is subject to meeting given criteria and obtaining the required permits, from the Authority.

Location of the designated spoil ground in Malta
Location of the designated spoil ground in Malta

Construction and demolition activities as well as dredging activities, substantially contribute to the amount of waste dumped at sea (see Table below).

YearDredged material
(tonnes)		Inert Waste
(tonnes)		Total
(tonnes)
2011140,3208,800149,120
20121,037,680-1,037,680
2013678,640-678,640
2014433,817-433,817
201577,76033,800111,560
2016-16,00016,000
2017425,000-425,000
Amounts of dredged material or inert waste disposed at sea in Malta, 2011-2017

Dredging in Malta

Dredging is the removal of material from the seabed, usually for maintenance of fairways for navigation of vessels or the development of port facilities. To date, disposal of dredged material in Malta has been at sea.

If not properly managed, dredging can have significant environmental impacts associated with the dredging process itself as well as with the disposal of dredged material. During both activities, impacts may arise as a result of loss or disturbance of benthic habitats, an increase in turbidity, changes in water currents (or hydrographical conditions), and release of contaminants accumulated within the dredged sediments, all of which can negatively affect water quality and marine ecosystems at the dredged and disposal locations.

The fate of dredged material depends on the level of contaminants present in the sediment.  In this context, prior to any dredging activity, a sampling plan shall be submitted to the Authority, for approval, in line with ERA’s Terms of Reference for the Management and Disposal of Dredged Material V.3.

The transfer of dredged material for the purposes of disposal at sea or disposal on land in a local non-hazardous landfill is subject to the Consignment Permit and Note Procedure.

The Waste Management (Landfill) Regulations S.L. 549.29, are the national legislation that regulate landfills and their impact, and aim to transpose the provisions of the Landfill Directive 1999/31/EC.

The Landfill Regulations aim to ensure a progressive reduction of landfilling of waste, in particular of waste that is suitable for recycling or other recovery. The objective of the regulations is to prevent or reduce as far as possible negative effects on the environment, in particular on surface water, groundwater, soil, air, and on human health from the landfilling of waste by introducing stringent technical requirements for waste and landfills.

The Landfill Regulations classify landfills into three classes, depending on the type of waste a landfill is permitted to receive:

  • Landfill for Hazardous waste;
  • Landfill for Non-hazardous waste; and
  • Landfill for Inert waste.

Flow chart explaining the three classes of landfill

The regulations outline which waste can be accepted at different classes of landfills, as well as which waste streams cannot be accepted at landfills.

  • Only waste which has been treated may be landfilled;
  • Hazardous waste, as defined by the Waste Framework Directive, is to be assigned to a hazardous landfill;
  • Landfills for non-hazardous may accept municipal waste and other non-hazardous waste; and
  • Landfill sites for inert waste must be used only for inert waste.

It is to be highlighted that there are currently no permitted hazardous waste landfills and inert waste landfills in the Maltese Islands. For permitted landfills, click here.

There are a number of waste streams that cannot be accepted at landfills:

  • Liquid waste;
  • Explosive or oxidising waste;
  • Flammable waste;
  • Corrosive waste;
  • Hospital and other clinical wastes which are infectious;
  • Whole and shredded tyres;
  • Waste which has been separately collected for preparing for re-use and recycling; and
  • Any other type of waste which does not fulfil the Waste Acceptance Criteria

The regulations also establish what information is necessary within an operating permit for a landfill site.

Furthermore, the landfill regulations also provide detailed guidelines on the requirements for an engineered landfill, as well as the necessary monitoring procedures and closure procedures, including:

  • General requirements for all classes of landfills;
    • Water control and leachate management;
    • Gas control;
    • Measures to minimise nuisances and hazards;
    • Stability of waste mass;
    • Barriers to prevent free access; and
    • Requirements for the temporary storage of metallic mercury.
  • Top, Bottom and Side sealing permeability requirements, depending on landfill class, for the protection of soil and water;
  • Control and monitoring procedures in operation and after-care phases; and
  • Closure and after-care procedures

Further information on the Landfill Directive may be found here.

The Maltese National Biosafety Clearing House was set-up in accordance with the Cartagena Protocol on Biosafety.

Malta ratified the Protocol on the 5th of January 2007. The Protocol seeks to protect biological diversity from the potential risks posed by living modified organisms, resulting from modern biotechnology. It establishes an advance informed agreement (AIA) procedure for ensuring that countries are provided with the information necessary to make informed decisions before agreeing to the import of such organisms into their territory. The Protocol came into force locally on the 5th of April 2007.

For any additional queries, you may check the frequently asked questions (FAQs)​, contact us via e-mail address on [email protected] or through telephone number 2292 3500.

Other links

Introduction

The release of a genetically modified organism (GMO) into the environment, without taking precise confinement measures, will result in contact between this GMO and the surrounding environment.

There are two broad categories of release of GMOs into the environment:

Deliberate release for any other purpose than for placing on the marketThat is, the introduction of GMOs into the environment for experimental purposes, also commonly known as field or clinical trials. These types of releases are mainly carried out for the purposes of study, research, demonstration and development of novel varieties. The behaviour of the GMO in an open environment and its interactions with other organisms and the environment are studied. In Legislation, these releases are referred to as Part B releases.
Placing on the market for commercial purposesIf the results of the experimental release are positive, the company may decide to place the GMO on the market, that is, make it available to third parties free of charge or for a fee. The GMO may be placed on the market for purposes of cultivation, importation or transformation of GMOs into industrial products. In Legislation, these releases are referred to as Part C releases.

 

Why and how are releases regulated?

Although considerable work has been carried out in the field of GMOs, and a large amount of data has been gathered, there are still concerns with regard to the safety of human health and the environment.

Consequently, in the EU and Malta, there are strict regulations that control the release of GMOs into the environment. The Deliberate release into the environment of genetically modified organisms regulations (S.L. 549. 60) give effect to Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms & repealing Directive 90/220/EEC. ERA is the designated Competent Authority in Malta for the implementation of these Regulations in terms of viable non-food/feed. Genetically modified food and feed are addressed through the Food safety commission.

The Regulations  apply to all GMOs, although plants have been the subject of most interest in recent years. The Regulations adopt a step-by-step approval process on a case-by-case assessment of the risks to human health and the environment before any GMO, such as maize, tomatoes, or microorganisms, can be released into the environment.

The entire regulatory process is underpinned by a detailed environmental risk assessment, prepared by the applicant, who examines and evaluates any possible harmful consequences of releasing a particular GMO.

Products derived from GMOs, such as paste or ketchup from a GMO tomato, are not covered by these regulations.

Getting approval for an experimental releaseLink
Procedural steps & timescales for the placing on the market of GMOsLink
Getting approval for placing on the marketLink
Procedural steps & timescales for the placing on the market of GMOsLink
GMOs authorised for experimental purposes in MaltaLink
GMOs authorised for placing on the EU marketLink

 

For any additional queries, you may check the frequently asked questions (FAQs)​, contact us via e-mail address on [email protected] or through telephone number 2292 3500.

Other links

The definition of ‘contained use’

“Contained use” is defined as any activity in which micro-organisms are genetically modified or in which such genetically modified micro-organisms (GMMs) are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with the general population and the environment.

An introduction to contained use

The term ‘contained use’ covers any activity involving genetically modified micro-organisms (GMMs) carried out under containment and in which measures are taken to limit contact between these organisms, people and the environment. It relates to the actual process of genetic modification, as well as to the use, storage, transport and destruction of GMOs.

Typical contained use facilities can be microbiology laboratories, animal houses, greenhouses or industrial production facilities. For example, before GMOs where invented, medicinal products such as insulin, blood factor VIII and human growth hormone, were formerly collected from dead humans and animals. These were collected in small amounts and always carried the risk of transmitting disease. Now, with the use of genetic modification (GM) technology, pure and safe equivalents can be produced in larger quantities using GM bacteria.

Why do we need controls and legislation?

A considerable number of contained use activities involve organisms that do not cause disease and are very unlikely to survive in the environment outside a containment facility. However, some contained use activities are carried out with more hazardous organisms whose escape from containment could result in adverse effects on human health and / or the environment. Therefore, it is very important to assess the risks of all activities and to make sure that any necessary controls are put in place to protect people and the environment.

Consequently, there is legislation in Malta and the EU to control and lay down measures for contained use activities. The Contained use of genetically modified micro-organisms regulations (S.L. 549.49) give effect to Directive 2009/41/EC on the contained use of genetically modified micro-organisms (Recast). The Environment and Resources Authority (ERA) is the designated Competent Authority in Malta for the implementation of these Regulations.

The legislation requires the applicant to carry out a thorough risk assessment, which is then reviewed by ERA. S.L. 549.49 outlines the risk assessment procedure that should be followed to determine which containment level is necessary and into which classification category the GMM and the proposed activity fall.

In some cases, there will not be an exact match between the containment and control measures, which the risk assessment indicates, and those specified for a particular class; i.e. the measures will effectively fall between two classes. In such cases, the activity applied for would be under the higher class.

Obligations under S.L. 549.49

Anyone carrying out contained use activities must comply with S.L. 549.49, particularly:

  1. Notify ERA of their intention to use their premises for contained use  activities for the first time;
  2. Carry out an assessment of the risks to human health and the environment of every contained use activity before it begins, reviewing and revising the assessment as necessary, and keeping records;
  3. Establish a genetic modification safety committee to advise on risk assessments;
  4. Classify all activities as described in the 4. Regulations;
  5. Apply the necessary containment and control measures indicated by the risk assessment, and;
  6. Draw up emergency plans for riskier activities, and notify any accidents that occur.

Classification of GMMs

Local and EU legislation classify GMMs into four classes:
Class 1Activities of no or negligible risk, for which level 1 containment is appropriate
Class 2Activities of low risk; for which level 2 containment is appropriate
Class 3Activities of moderate risk, for which level 3 containment is appropriate
Class 4Activities of high risk, for which level 4 containment is appropriate

Most genetically modified plants are considered Class 1 because they are not usually modified to contain DNA sequences from human disease-causing organisms. Class 4 is reserved for highly dangerous human or animal pathogens such as small pox, which are highly transmissible and for which there is no prophylaxis.

Application procedures

For application procedures, click here.

For any additional queries, you may check the frequently asked questions (FAQs)​, contact us via e-mail address on [email protected] or through telephone number 2292 3500.

Other links

The activities listed below are extracted from Schedule I of S.L. 549.79  and may require an environmental permit to be carried out.

Adhesive Coating

Any activity in which an adhesive is applied to a surface, with the exception of adhesive coating and laminating associated with printing activities. Adhesive coating involves the application of adhesives by spray, roller, brush and other techniques to a variety of substrates

Coating Activity

Any activity whereby a single or multiple application of a continuous film of coating is applied to the following

    • Vehicles including:
      • New cars (defined as vehicles of category M1)
      • Truck cabins (defined as the housing for the driver of vehicles of categories N2 and N3)
      • Vans & trucks (defined as vehicles of categories N1, N2 and N3)
      • Buses (defined as vehicles of categories M2 and M3)
      • Trailers (defined in categories O1, O2, O3 and O4)
    • Other coating, including metal, plastic, textile, fabric, film and paper coating
    • Coating of wooden surfaces
    • Coating of leather
Coil Coating

Any activity where coiled steel, stainless steel, coated steel, copper alloys or aluminium strip is coated with either a film forming or laminate coating in a continuous process. A wide variety of coating formulations is used by the coil coating industry. The more prevalent coating types include polyesters, acrylics, polyfluorocarbons, alkyds, vinyls and plastisols.

Dry Cleaning

Any industrial or commercial activity using VOCs in an installation to clean garments, furnishing and similar consumer goods with the exception of the manual removal of stains and spots in the textile and clothing industry. Installations providing laundry services only shall be excluded from this list.

Footwear Manufacture

Any activity of producing complete footwear or parts thereof. The VOC emissions in the production of footwear result mainly from adhesives containing organic solvents. The content of organic solvents in shoe adhesives is around 75 – 80 % (weight per cent). Solvent based adhesives have a portion of 67 %, adhesive dispersions have a portion of 16 % and hotmelts have a portion of 17 % of the sectors´ total consumption.

Manufacture of coating preparations, varnishes, inks and adhesives

The manufacture of any coating preparations, varnishes, inks and adhesives. This also includes the manufacture of intermediates (where carried out at the same site), by mixing of pigments, resins and adhesive materials with organic solvent or other carrier, including dispersion and predispersion activities, viscosity and tint adjustments and operations for filling the final product into its container.

Manufacturing of Pharmaceutical Products

The chemical synthesis, fermentation, extraction, formulation and finishing of pharmaceutical products and where carried out at the same site, the manufacture of intermediate products. It is important to note that pharmaceutical companies manufacturing API’s (active product ingredients) are subject to IPPC permits, while the production of other pharmaceutical products, including intermediates, requires an environmental permit.

Printing Activities

Any reproduction activity of text and/or images in which, with the use of an image carrier, ink is transferred onto whatever type of surface. It includes associated varnishing, coating and laminating techniques. However, only the following sub-processes are subject to these regulations:

  • Flexography: A printing activity using an image carrier of rubber or elastic photopolymers on which the printing areas are above the non-printing areas, using liquid inks which dry through evaporation. Flexography is a web-fed process and is mainly used to print packaging materials such as plastic films and metal foils.
  • Heatset web offset printing: a web-fed printing activity using an image carrier in which the printing and non-printing area are in the same plane, where web-fed means that the material to be printed is fed to the machine from a reel as distinct from separate sheets. The non-printing area is treated to attract water and thus reject ink. The printing area is treated to receive and transmit ink to the surface to be printed. Evaporation takes place in an oven where hot air is used to heat the printed material.
  • Laminating: A process which is normally associated to a printing activity. This involves the adhering together of two or more flexible materials to produce laminates.
  • Publication rotogravure: A rotogravure printing activity used for printing paper for magazines, brochures, catalogs or similar products, using toluene-based links.
  • Rotogravure: A printing activity using a cylindrical image carrier in which the printing area is below the non-printing area, using liquid inks which dry through evaporation. The recesses are filled with ink, and the surplus is cleaned off the non-printing area before the surface to be printed contacts the cylinder and lifts the ink from the recesses.
  • Rotary screen printing: A web-fed printing activity in which the ink is passed onto the surface to be printed by forcing it through a porous image carrier, in which the printing area is open and the non-printing area is sealed off, using liquid inks which dry only through evaporation. Web-fed means that the material to be printed is fed to the machine from a reel as distinct from separate sheet
  • Varnishing: An activity by which a varnish or an adhesive coating for the purpose of later sealing the packaging material is applied to a flexible material.
Rubber Conversion

Any activity of mixing, milling, blending, calendaring, extrusion and vulcanization of natural or synthetic rubber and any ancillary operations for converting natural or synthetic rubber into a finished product.

Surface Cleaning

Any activity except dry cleaning using organic solvents to remove contamination from the surface of material including degreasing. A cleaning activity consisting of more than one step before or after any other activity shall be considered as one surface cleaning activity. This activity does not refer to the cleaning of the equipment but to the cleaning of the surface of products. It is important to note that EU Directive 1999/13/EC states that substances which because of their content of VOCs are classified as R40, R45, R46, R49, R60, R61 or R68 should be replaced by less harmful substances or preparations within the shortest possible time.

Vegetable oil & animal fat extraction and vegetable oil refining activities

Any activity to extract vegetable oil from seeds and other vegetable matter, the processing of dry residues to produce animal feed, the purification of fats and vegetable oils derived from seeds, vegetable matter and/or animal matter.

Vehicle Refinishing

Any industrial or commercial coating and /or degreasing activities carried out on new road vehicles (i.e. from the original manufacturing line) and trailers (including semi-trailers). This means that vehicle refinishing carried out as part of vehicle repair, conservation or decoration outside of manufacturing installations is not included within this list and hence does not fall within scope of SL 549.79.

Winding Wire Coating

Any coating activity of metallic conductors used for winding the coils in transformers and motors, etc. Solvent is used in several coating processes. Coatings contain 60-70% solvents by weight. Firstly, solvent is used for coating the wire with enamel, essential in enabling the enamel to stick to the wire. Secondly, a wax layer is applied on top of the enamel layer. This latter process uses the greatest proportion of solvents. In general, solvent-relevant process steps include the coating and could be also the lubricating process.

Wood Impregnation

Any activity giving a loading or preservative in timber. The application of the preservative may be carried out via vacuum processes, pressure processes, dipping, spraying or brushing. The application efficiency of the vacuum process, dipping and brushing is close to 90 %. Spraying has a much lower efficiency of around 10 %. The main emission source is given by the solvent content of the applied substances. Three types of preservatives are used: water-based ones, solvent-based ones and creosote.

Wood and Plastic Lamination

Any activity to adhere together wood and/or plastic to produce laminated products. Most common solvents used within this industry include hexane, methyl ethyl ketone, toluene, and methylene chloride.

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Trade is one activity that can lead to negative impacts on species, especially on endangered species.  A number of such species have experienced serious decline in populations due to demand either for the specimens themselves, or for parts or derivatives therefrom.

Trade-related impacts on species are addressed on an international basis by the Convention on International Trade in Endangered Species of Wild Fauna and Flora. Known as CITES, this Convention aims at ensuring that international trade does not threaten wild plant and animal species. It does this by subjecting trade to controls on import, export and re-export of species by applying compliance controls and certifications. Differences apply whether goods are being moved within the European Union, where there is freedom of trade and hence lesser controls, or whether there is trade to or from outside the European Union.

The vulnerability of the species concerned, and the demand levels for the said species all contribute to different classifications and levels of protection by CITES and ensuing legislation.  There are three different appendices in CITES, and four Annexes in the European Union’s Regulation on the Protection of Species of Wild Fauna and Flora by Regulating Trade Therein (EU Regolament / Regulation), and different species are listed in the said Appendices and Annexes depending on the extent of how threatened the species are and the extent of trade activities targeting them. These legal documents are transposed into Maltese law (S.L.549.38​).

Many people are quite mistaken in thinking that CITES only concerns exotic animals such as tigers or bears, or parts from such animals like elephant tusks and rhino horns, and that members of the general public are not really affected by its implications. In reality, many commonplace goods and transactions involve CITES species or derivatives. Many species of pets, such as tortoises and parrots, are CITES-listed, and so are many birds of prey.  Food delicacies such as caviar (eggs of sturgeon), certain high quality timber used in furniture or musical instruments, such as rosewoods and certain mahoganies, the leather derived from certain animal species such as that of alligators, many cacti species, and various plant extracts used in the manufacture of cosmetics, health supplements and diet pills, are CITES-listed and require compliance checks and pre-authorisations especially when imported from outside of the EU. Sale of Annex A species within the European Union, including therefore within Malta itself, also requires certification. Maltese law stipulates that the owners of CITES-listed species must always keep the relevant CITES documentation available. Hence anybody acquiring such specimens from third parties are obliged by law to be in possession of these documents. Failure to do so may result in the specimen being seized and action taken against the owner.

Applying for CITES clearances

It is recommended that anybody considering bringing into Malta (including via the purchase of items over the internet) any products derived from plants or animals from outside the European Union, and any live animals or carcasses (e.g. hunted animals/birds) both from within and from outside the European Union, or is considering acquiring any live or dead animal even from Malta itself, contacts the Environmental Permitting Services  in advance to confirm whether any CITES requirements need to be complied with.  It is to be pointed out that if an item arrives at the border control without any necessary CITES certificates, it would be seized and action taken against the importer.

In Malta, the the Environment & Resources Authority (ERA), which is the CITES Management Authority of Malta, processes more than 75 CITES compliance certifications or clearances per week for transactions covering specimens/items imported from or exported/re-exported out of the European Union. Various traded items all require CITES compliance clearance prior to being imported (or exported). Pet shop fish and coral, fresh-frozen fish for human consumption, cosmetics, medicinals​, clothes, timber products, etc. constitute such goods.

CITES compliance clearances

In order for the ERA to issue a compliance clearance on any item for it to be released on its importation, information is required on the materials being imported/exported, and/or ingredients contained in products. A declaration from the supplier is to clearly state whether any plant or animal products, derivatives, or parts thereof, are included in the items being imported/exported. The declaration should clearly refer to the invoice in question or particular items in the invoice, as necessary. The declaration should cover all items on the invoice as the CITES office will release all the invoice and not specific items on the invoice. The above information is necessary for items or products being imported from a non-EU country, even if the products were originally produced within an EU country.

In the case of exports, the information above is necessary for items or products being exported to a non-EU country, even if the items or products originally reached Malta from an EU country.

For further information contact ERA on https://era.org.mt/contact/

Application forms

For application form, click here.

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The Application Process

An application for an IPPC permit is submitted to ERA using standard forms. In their application, companies must:

  • Submit a description of their proposed activities;
  • Provide details of how the site will be managed and nominate a technically competent person;
  • Indicate the potential for releases of emissions and waste generation and how these will be minimised and monitored;
  • Specify the raw materials, water and energy use of the activity and how resources will be used efficiently;
  • Indicate how the site will be returned to a satisfactory site after operations cease.

Applications may be submitted through the ERIS System which may be accessed from here. Application fees as listed within S.L. 549.77 are to be settled for the validation and further processing of the application.

In addition to submitting the application form to ERA, applicants are required to submit a soft copy to the consultees identified by Regulation 19(2) of the Industrial Emissions (IPPC) Regulations. A signed delivery note is required to be submitted as part of the application submitted to ERA.

The application is assessed by ERA in consultation with the consultees identified by Regulation 19(2) of the Industrial Emissions (IPPC) Regulations, SL 549.77. ERA may ask for further information until enough information is available for a decision. The application is then made public on ERA’s website, ERA’s front office and the local council of the locality in which the installation is proposed, for a period of 30 days during which time the public is invited to comment.

After permitting, the permit application and the permit are made available to the public on ERA’s website. Submissions made as part of permit conditions and inspection reports may also be placed on the website.

Variations of the IPPC Permit

The IPPC permit is a dynamic permit, and may be varied should the Authority think it is necessary to do so, or if the operator makes a request. In the case of substantial changes, a 30-day public consultation period will be required prior to the Authority making a decision, whereas for minor variations a 15-day consultation period may be applicable. Please contact the Environmental Permitting Unit to apply and for further information.

Applying for renewal of the permit

IPPC permits are valid for a specific period, and the operator needs to submit an application for renewal within the time frame specified in the installation’s IPPC permit. An application for renewal should include the following information:

  1. An indication of how the improvements required by the IPPC permit have been implemented;
  2. A comparison of the operation of the plant with the latest relevant BAT conclusions, where applicable;

Please contact the Environmental Permitting Unit on  https://era.org.mt/contact/ to apply and for further information.

Last Updated: 25/06/2025