Archives: Oferta

Synthetic substances

We test starting materials, the final medicinal product, and active substances. We have permission from the Chief Pharmaceutical Inspectorate (GIF) to produce medicinal products in the field of physicochemical tests. Our laboratory complies with the principles of Good Manufacturing Practice (GMP) in the field of testing medicinal products for humans and animals, which is confirmed by the GMP Certificate.

Services in the area of GMP for synthetic substances:

  • Screening, qualification, and validation of methods for determining elements in API and finished products using the ICP-MS technique in accordance with Ph. Euro. and USP.
  • Transfer of analytical methods – from, and to the J.S. Hamilton Laboratory.

Vegetable substances

We test starting materials, the final medicinal product and active substances. We have permission from the Chief Pharmaceutical Inspectorate (GIF) to produce medicinal products in the field of physicochemical tests. Our laboratory complies with the principles of Good Manufacturing Practice (GMP) in the field of testing medicinal products for humans and animals, which is confirmed by the GMP Certificate.

Services in the area of GMP for plant substances:

  1. testing the content of pesticide residue,
  2. dithiocarbamate content tests,
  3. tests for the content of aflotoxin B1 and total aflatoxin,
  4. testing the content of pyrrolizidine alkaloids.

Product certification

J.S. Hamilton Poland – Certification Body, based in Siemianowice Śląskie, conducts mandatory and voluntary certification of products for compliance with the requirements of standards, technical specifications, etc:

  • within the scope of PCA accreditation No. AC 149,
  • within the scope of the Directives on the basis of the European Notification,
  • of IECEx requirements
  • outside the scope of accreditation,
  • for the “B” safety mark (trademark-guarantee)

Certification of products conducted in accordance with the requirements of standards included in the scope of accreditation AC 149 granted by the Polish Centre for Accreditation is carried out on the basis of type 1a, 1b or type 3 certification programmes developed on the basis of the requirements of PN-EN ISO/IEC 17067.

 

J.S. Hamilton Poland – Certification Body has European Notification 2057.

Certification of products carried out in accordance with the essential safety requirements of the Directives based on harmonised standards or the requirements of the Directive itself.

  • We operate in the areas of Directives:2014/34/UE – ATEX Directive <jako link do badania techniczne i certyfikacja / Dyrektywa ATEX>
  • 2014/30/UE – EMC Directive <jako link do badania techniczne i certyfikacja / Dyrektywa EMC>
  • 2006/42/WE – MD Machinery Directive <jako link do badania techniczne i certyfikacja / Dyrektywa MD>

J.S. Hamilton Poland – accredited by the IECEx organisation, we operate in the field of:

  • product testing carried out in accordance with the requirements of IEC standards,
  • certification of products conducted in accordance with the requirements of IEC standards,
  • Quality Assessment Report QAR.

In addition, we carry out voluntary certification processes for compliance with technical requirements, legislation and standards and specifications outside the scope of accreditation for products from a wide range of industries:

  • rail,
  • mechanical
  • electrical engineering
  • energy,
  • automotive,
  • WHITE GOODS,
  • construction,
  • rubber and plastic products,

As part of the agreement with the Polish Association for Technical Research and Accreditation,.S. Hamilton Poland – Certification Body, based in Siemianowice Śląskie, conducts voluntary certification for the “B” safety mark (guarantee product).

The certification is based on safety requirements specified by national and international standards, technical specifications, regulations and other legal requirements.

The principles of certification for the Common Guarantee Mark “B” are defined in the Scheme of Product Certification for the Common Guarantee Mark “B”.

 

Agro-Eko certification for agricultural production

 

Centrum Jakości AgroEko Sp. z o.o. is a limited liability company established by a notarial act on 2007-07-09.                   The company was registered in the National Register of Companies on 2007-07-23 under the register number 0000285181, and since 2016 it has been a member of the J.S. Hamilton Poland Sp. z o.o. Capital Group.

 

THE PRIMARY OBJECTIVE OF THE QUALITY CENTRE AGROEKO SP. Z O.O. IS:

  • certification of organic production operators,
  • certification of operators with regard to the QAFP system,
  • certification of producers for Integrated Plant Production,
  • certification of operators for the PQS system,
  • certification of the customer’s internal systems.

We are accredited by the Polish Centre for Accreditation – AC 148 and we are authorised by the Minister of Agriculture and Rural Development to act as a certification body in organic farming – PL-EKO-09.

In all activities undertaken by us, we guarantee professionalism, quality and independence.

 

logo integrowana produkcjaQAFP logo

 

ATEX certification

Notified Body (NB 2057) J.S. Hamilton Poland – Certification Body, based in Siemianowice Śląskie, as a third party has the capability to carry out mandatory and voluntary conformity assessment of products based on the requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.

Products intended for use in potentially explosive atmospheres must comply with the essential health and safety requirements of European Union Directive 2014/34/EU commonly referred to as the ATEX Directive. In order to determine whether a product meets the requirements of the directive, appropriate conformity assessment procedures must be applied.

According to the ATEX Directive, the level of protection and the associated assessment procedures depend directly on the level of hazard and the environment in which the equipment will operate.

The Certification Body for product groups I and II of category M1 and 1, respectively:

  • electrical appliances,
  • non-electrical equipment,
  • parts and components,
  • safety, control and regulation apparatus,
  • protection systems

for Group I and II products, categories M2 and 2:

  • internal combustion engines,
  • electrical equipment,
  • cparts and components,
  • protection, control and regulation apparatus,
  • medium and low voltage motors.

carries out the following conformity assessment procedures according to modules:

  • Module B: EU type examination (Annex III),
  • Module D: Conformity to type based on quality assurance of the production process (Annex IV),
  • Module F: Conformity to type based on product verification (Annex V),,
  • Module C1: Conformity to type based on internal production control and supervised product testing (Annex VI),
  • Module E: Conformity to type based on product quality assurance (Annex VII)
  • Module A: Internal production control (Annex VIII) + Transfer of technical documentation
  • Module G: Conformity based on unit verification (Annex IX)

 

The necessary tests required to confirm the explosion-proof performance of group I and II equipment of categories M1 and 1 and M2, 2 and 3 respectively are carried out in our own accredited testing laboratory No. AB 1552.

In addition to the obligatory EU Type Examination assessment, we carry out the non-obligatory Type Examination certification process for non-electrical equipment of categories M2 and 2 and equipment of category 3. This is an excellent way of confirming the conformity of products if you want the construction as well as the documentation to be verified by specialists. The process is similar to the EU Type Examination assessment, but applies to products for which no mandatory certification is required. The Type Examination Certificate does not, however, release you from additional procedures specific to the category and type of product, e.g. retention of documentation.

Module A: Internal production control (Annex VIII) + handing over of technical documentation applies mainly to the manufacturer, it is his responsibility to carry out the process of design, production, product quality supervision in accordance with the requirements of the essential safety requirements of the ATEX Directive. As an additional activity to which the manufacturer must pay attention is the retention of the documentation in the Notified Body. Documentation should be retained for 10 years after the end of production. The Notified Body of J.S. Hamilton accepts documentation in both paper and electronic form.

Microbiological testing

Microbiological testing of products is synonymous with a safe product. Each link in the supply chain should follow high hygiene standards so that the end recipient can be sure of the product’s safety.
We offer microbiological tests of dietary supplements, herbs, raw materials and pharmaceutical products with reference methods and according to the Pharmacopoeia. For selected types of products, we offer quick tests (TEMPO, BAX) with the results ready after 24 hours.

Our test portfolio includes:

  • Mesophilic aerobic bacteria,
  • Moulds and yeasts (fungi),
  • Escherichia coli,
  • Coliform bacteria,
  • Stapchylococcus aureus,
  • Salmonella,
  • Listeria monocytogenes,
  • Enterobacteriaceae.

We offer the determination of probiotic bacteria in probiotics:
The number of Lactobacillus spp, Bifidobacterium, Streptococcus thermophilus.

 

Electrical testing, LVD

The test laboratory in Siemianowice Śląskie carries out tests in the following areas

measurements of direct and alternating voltages

  • alternating and direct current measurements
  • frequency and capacitance measurements
  • inductance measurements
  • resistance measurements and diode tests
  • leakage resistance to earth (floors, work surfaces, shelves, trolleys, chairs)
  • resistance of the “man/shoe/floor” system (effectiveness of earthing through ESD shoes and the floor in question)
  • point-to-point resistance (floors, work surfaces, flat materials, clothing), electrification,
  • electrical insulation strength
  • insulation resistance of cable lines, transformers, motors and other electrical equipment, also equipment used in telecommunications,
  • insulation clearances
  • capacity of cells and batteries,
  • short-circuit resistance of cells and batteries,
  • protection against residual voltage
  • continuity of protective circuitry and resistance of protective and equalising circuits,
  • surface resistance RS, RV cross resistance, resistance between RP points of non-metallic materials,
  • resistance of pipes and hydraulic hose made of plastic and rubber,
  • thermal – heating, temperature rise, maximum temperature
  • using contact and non-contact methods (thermal imaging),
  • intrinsically safe systems.

We carry out tests in the field of European, IEC and national standards, among others.

  • EN 60204 Series of standards
  • EN ISO 9241 series of standards
  • EN 62208 Series of standards
  • EN 61439 Series of standards
  • EN 60598 Series of standards
  • Series of standards PN-EN-IEC 598
  • EN 60335 Series of standards
  • Series of standards PN-EN IEC 62368
  • Series of standards EN 60950
  • EN 60950 Series of Standards EN 61851
  • EN 60068 Series of standards
  • EN 50305 series of standards
  • Standards series PN-G-50000

 

Our wide range of studies includes:

Electrical and electronic equipment, including household appliances and consumer electronics, computers, lighting, electrical equipment for machinery and equipment,

Testing of luminaires, industrial, emergency and domestic lighting, within the scope of PN-EN 60598 standards

Testing of teletechnical and telecommunications equipment, printers, cash registers,

Electrical energy storage devices, UPS, electric vehicle charging stations.

Testing of LV switchgear, empty switchgear enclosures, transformer stations.

 

Electrical equipment for use in explosive and non-explosive atmospheres, for example:

  • electrical rotating machines,
  • electrical transformers,
  • switches and switchgear,
  • fixed and portable luminaires,
  • battery and rechargeable lamps,
  • fuses,
  • sensors, measuring transducers and control and measurement apparatus,
  • communication and signalling equipment,
  • direct current power supplies,
  • automation, control and transmission equipment.

 

Equipment operating in explosive atmospheres,

Intrinsically safe systems,

Protection measures and safeguards in mine electrical power engineering – leakage protection, protective conductor earthing systems, short circuit and overload protection,

Mine AC switchgear for voltages above 1 kV up to and including 15 kV,

Mining through-holes for cables for rated voltages up to 6/10 kV,

Electrical insulating materials,

Power relays, measuring relays and protective devices,

 

Vehicles, machinery and equipment in particular:

  • mining rail locomotives,
  • overhead tractors,
  • mining machinery for extracting, loading and hauling,
  • free-wheeling drum winches,
  • diesel-powered mining machinery and equipment,
  • underground equipment in the field of dust extraction, wetting and spraying equipment,
  • machinery for grinding and crushing materials,
  • pumps, generators and compressors,
  • gearboxes, transmissions, drive bridges,
  • electric motors of standard and explosion-proof construction,
  • mining machinery and equipment for the transport and mechanical processing of coal,
  • general-purpose mobile platforms,

 

The laboratory is accredited by the Polish Centre for Accreditation in the field of electrical and electronic measurements. Full scope of our accreditation AB 1552 .

Microbiological purity tests and preservation tests

Microbiological purity of cosmetics and personal care products play a key role to determine their safety. Microbiology testing services help to minimize the risk of potential damage. Therefore manufacturer should maintain microbiological quality of products as industry is constantly challenged to develop safe, effective, and compliant products that meet the requirements of both legislation and consumers.

We provide accredited testing for identification of microorganisms to meet requirements:

  • EN ISO 16212 – enumeration of yeast and mold in cosmetics
  • EN ISO 21149 – general guidelines for enumeration microorganisms
  • EN ISO 22718 – detection of Staphylococcus aureus in cosmetics
  • EN ISO 22717 – detection of Pseudomonas aeruginosa in cosmetics
  • EN ISO 18416 – detection of Candida albicans in cosmetics
  • EN ISO 21150 – detection of Escherichia coli in cosmetics

Challenge test confirm that the used preservatives protect the cosmetic product against the development of dangerous microorganisms and protect it against the development of secondary infections during use. They consist in the infection of the tested cosmetic mass with the strains of Pseudomonas aeruginosa, Staphylococcus aurerus, Candida albicans and Aspergillus brasiliensis and the observation of the reduction of microorganisms over time.

In our laboratory, we perform challenge tests in accordance with:

  • EN ISO 11930: 2019-03 with accreditation,
  • Eur. 5.1.3. (European Pharmacopoeia method),
  • the S&M Koko Test method,
  • in selected cases, with the customer’s methodology.

 

Challenge test is carried out at different stages of production and storage:

  • at the product development stage (in order to obtain the correct preservative system),
  • during production (to confirm that the technological process has no negative impact on the durability of preservatives and their effectiveness),
  • to protect the cosmetic product in the event of unforeseen contamination during production and during use by the consumer,
  • to evaluate the action against environmental strains that pose microbiological problems.

Lab Testing Services

J.S. Hamilton Poland Sp.z o.o. petroleum testing services support the entire petroleum products range: gasoline, diesel, fuel oil, residual oil, base oils, slack wax, paraffin waxes, crude oil, LPG, propane, butane, propylene, natural gas, coal, coke, biomass, chemicals, alcohols. Our sate of the art laboratory at Małaszewicze provides rapid fuel analysis, reliable results, with a competitive value in lab service necessary for customs clearance.

J. S. Hamilton Poland Sp.z o.o. – laboratory testing services

The independent petroleum testing J.S. Hamilton Poland Sp.z o.o. accredited labs conducts analysis which are basis for financial settlements and provide reliable information about the quality of controlled goods.

 

J.S. Hamilton Poland Sp.z o.o. testing laboratories conducts petrochemical testing:

  • motor fuel – gasoline, diesel
  • liquefied petroleum gas – LPG, propylene, propane, butane and other
  • methane-rich gas – natural gas, LNG, CNG, biogas
  • biocomponents in fuel – bioethanol, fatty acid methyl esters (FAME)
  • fuel oil (heavy and low)
  • marine fuel
  • crude oil
  • slack and paraffin waxes
  • petrochemical products and chemicals
  • coal, coke
  • combustion waste
  • biomasses, alternative fuel
  • oils
  • petroleum mixtures composition identification
  • impurities in technological and utility installations identification

National And International Transportation, Shipping

J. S. Hamilton Poland Sp.z o.o. provides the present transportation industry with efficient and coordinated services and the confidence that products meet required safety and quality standards. We also ensure rapid clearance and transport from the place of origin to the destination.

The services Hamilton provides to the transportation industry cover all aspects of our clients’ needs from freight forwarding, agency and more.

Our offer is aimed primarily at companies engaged in export/import/transit of agricultural, foods and other bulk commodities and general cargo, including:

  • implementation of sea and land freight transportation, logistics services both bulk commodities and general cargo for import, export and transit of goods, such as:
    • grains, feed and oilseeds
    • oils and fats
    • foods such as, sugar, rice
  • customs clearance
  • assistance in obtaining relevant certificates, such as: Phytosanitary Certificate, Certificates of Origin, EUR1, T5 etc.
  • marine and land cargo risk and liability services
  • cargo of vegetable origin packaging and storage in warehouses
  • chartering of vessels and other means of transport
  • agencies in ports
  • national and international land transportation

Client’s using our services are ensured that all problems with goods export and import are carried out risk-free. They receive full rage of services loading and discharge supervision, also are kept informed about deliveries to the port/destination, and the settlement of any other formalities associated with goods’ transportation. All services are performed by a team of experienced professionals, with significant achievements in their fields of expertise.

Fumigation

J.S. Hamilton Poland Sp.z o.o. provides comprehensive pest control solution system in warehouses, as well as emergency activities supporting services related to disinfection, disinsection and deratisation. Our company delivers practical disinfection, disinsection and deratisation and fumigation service solutions to safeguard businesses such as shipping and cargo, manufacturing, warehousing etc. Our goal is professional pest fumigation treatments to keep your environment pest-free and compliant with healthy and safety regulations. Moreover, we have adequate liability insurance policy regarding business activities. The effectiveness of performed treatment is a priority for us. With a long experience in fumigation services, J.S. Hamilton Poland Sp.z o.o. guarantees high quality of services, highly trained and experienced technicians, professional consulting and treatments followed by appropriate certificates.

 

Across Poland we provide a wide range of comprehensive fumigation services in all agricultural and foods commodities using classic method and J-system recirculation method.

OUR OFFER:

  • containers fumigation
  • cargo grain fumigation
  • grain in silo, chambers, warehouses, wagons fumigation
  • empty container fumigation
  • J-system recirculation
  • ventilation after fumigation with certificate

For fumigation services we provide specialized safety equipment, including: gas masks, gas detectors, safety protocols. Every fumigation is followed by international certificate.

ACTIVITY

We provide fumigation services across Poland, in business such as:

  • cereal grain mills, grain silos and stores
  • ports
  • container in terminals
  • ships
  • shipyards
  • bakeries, confectionery
  • hotels
  • warehouses
  • food and agricultural companies
  • historical sites
  • museum artifacts

Port inspections

J.S. Hamilotn Poland Sp.z o.o. offers full qualitative and quantitative control of all commodities imported and exported from Polish ports such as Gdynia, Gdańsk and Szczecin.

Inspection and control services

  • weight determination of break bulk – weighing supervision (calibrated scales, wighbridge etc.) draft survey and measurement is warehouses
  • determination of liquid bulk storage tank, ullage, measurement of inland tanks
  • tank and hold cleanliness
  • sampling
  • supervision of cargo loading, discharging and storage
  • photographic reporting
  • inspection reports in Polish and English languages
  • advisory and training

Inspected goods:

  • grain, oilseeds, pulses, oilseed middlings
  • vegetable oils and animal fats
  • dairy products
  • foods – sugar, fruits, vegetables, spices
  • break bulk cargo – steel products
  • minerals and chemicals – coal, coke, ores, metals, fertilizer, aggregates
  • scrap and steel products
  • biomass

We also provide inspection and control of exported grain commodity in warehouses.

Laboratory analysis

Our agriculture laboratory, situated close to port terminals, provide comprehensive cereals testing.

Offer includes: 

  • organoleptic evaluation – odor, color, pest infestation
  • foreign matter

Apart from classic analytical testing methods, our laboratories provide a rapid instrumental technique for the analysis of cereals (NIR) with FOSS and PERTEN instruments of the following parameters:

  • moisture
  • protein in dry matter
  • gluten
  • density
  • falling number
  • oil content in rapeseed

Dangerous substances in articles

REACH AND OTHER REGULATIONS ON CONSUMER GOODS:

  • heavy metals,
  • PAHs (polycyclic aromatic hydrocarbons), e.g. benzo[a]pyrene,
  • phthalates,
  • PAAs and AZO dyes,
  • SCCP, MCCP, LCCP (Short / Medium / Long-Chain Chlorinated Paraffins),
  • BPA (Bisphenol A), BPS (Bisphenol S) and other bisphenols,
  • PFAS,
  • testing acc. to Toy Safety standard EN 71 series such as EN 71-3, EN 71-9/-10/-11, EN 71-12,
  • testing of substances acc. RoHS Directive,
  • testing against special requirements and specifications of you clients, e.g. retailers, brand owners (RSLs, Toxic & Restricted Substances Lists).

Chemical analyses

J.S. Hamilton Poland Sp. z o.o. Laboratory offers a wide range of tests of toys and products for children and infants. We perform accredited tests of toy safety to declare their compliance with the requirements of standards harmonized with Directive 2009/48/EC (Toys Safety Directive) and the following standards of other types:

SAFETY OF TOYS

PN-EN 71-3+A1

Part 3: Migration of certain elements

Aluminium, Antimony, Arsenic, Barium, Boron, Cadmium, Chromium (III), Chromium (VI), Cobalt, Copper, Lead, Manganese, Mercury, Nickel, Selenium, Strontium, Tin, Migration of organic tin to simulated gastric acid, Zinc

PN-EN 71-8:2012

Part 8: Activity toys for domestic use

PN-EN 71-9, 10 and 11

Parts 9, 10, 11: Organic chemical compounds, including:

Flame retardants, Colourants, Primary aromatic amines, Monomers, Solvents-migration, Solvents-inhalation, Wood preservatives, Preservatives, Plasticisers

HAZARDOUS SUBSTANCE DETERMINATION

Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

Phthalates, Primary Aromatic Amines, Azocolourants, Polycyclic aromatic hydrocarbons (PAHs).

ROHS

Directive 2011/65/EU of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) Content of mercury, lead, cadmium, chromium VI, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE).

Water

Water is an essential component for the life of every organism, and we will help you take care of its quality. The J.S. Hamilton laboratory offers microbiological and physicochemical tests for quality and purity:

  • drinking water (tests for the needs of the Department of Health, tests in accordance with the regulation),
  • groundwater from the well, from the water intake supplied by the well (borehole, dug well, piezometers) in order to use it for economic and / or drinking purposes,
  • research of surface waters – lakes, rivers, bathing areas,
  • pool water testing,
  • technological water testing,
  • for the presence of Legionella in accordance with ISO 11731: 2017.

We have a wide range of accreditation and valid sanitary inspection approval.

Contact us today if you would like to learn more – or to schedule testing for your water samples.

Accredited sampling and field measurements

We provide accredited sampling, field measurements and transport of samples throughout Poland.

Our team of qualified samplers in connection with a fleet of over 60 specialized cars and the Geotask collection planning logistics system allows us to provide services anywhere in the country.

Accredited collection with the use of professional equipment and refrigerated transport of laboratory samples guarantee the high quality of our services.

Consultancy Services

J.S. HAMILTON POLAND IS:

  • a leading laboratory in testing of packaging for food, cosmetics and pharmaceuticals in Central & Eastern Europe,
  • an independent research center offering knowledge and experience as well as a wide range of analytical methods,
  • a reliable Partner of Food, Packaging, Plastics Processing and Paper Industry,
  • expert team ensuring impartial assessment of the Quality, Compliance and Safety of Products.

We support our Partners’ business growth and development, confirm their credibility, responsibility & innovation.

J.S. Hamilton Poland Sp. z o.o. is a laboratory that comprehensively combines consultancy services with comprehensive analytical research. Our experts team ensures an independent assessment of the quality of products.  The central laboratory in Gdynia and a network of specialized local laboratories have been offering a wide range of accredited physic-chemical, microbiological and sensory analyzes since 1949.

J.S Hamilton’s experts advise the appropriate and optimized configuration of testing plan in order to ensure compliance with the relevant national and European safety regulations, as well as with specific requirements of  clients, organizations, Brand Owners and retailers.

We offer the following consultancy services:

  • documents review and verification,
  • set-up of optimized testing plans for compliance assessment,
  • compliance assessment based on EU 10/2011, Swiss Ordinance, BfR Recommendations and relevant, Industry Guidance (EuPIA, CEPI, FCA, FEICA, JRC, EFSA, EDQM)
  • toxicological risk assessment – e.g., by TTC-concept method,
  • drafts of DoC (Declaration of Compliance) for final FCMs,
  • trainings.

Food comes into contact with many materials and articles during production, processing, storage, preparation and serving, before its eventual consumption. Such materials and articles are called Food Contact Materials (FCMs). Food contact materials are either intended to be brought into contact with food, are already in contact with food, or can reasonably be brought into contact with food or transfer their constituents to the food under normal or foreseeable use. This includes direct or indirect contact.

Food contact materials (FCMs) are widely used in everyday life in the form of food packaging, dishes and utensils, tableware, food containers, etc. When put into contact with food, the different materials may behave differently and transfer their components to the food. If transferred in large quantities, many chemicals might endanger human health, or change the food itself. Therefore, food contact materials are subject to legally binding rules at EU level, currently laid down in Regulation (EC)1935/2004, which aims at ensuring FCM safety but also the effective functioning of the internal market in FCMs raw materials and final products. The purpose of this framework legislation for FCMs is to ensure the effective functioning of the internal market for materials and articles intended to come into contact with food and secure a high level of protection of human health, as well as the interests of consumers.

(EC)1935/2004 provides general requirements that all FCMs must be manufactured in accordance with good manufacturing practice (GMP) so that they are safe and do not change the properties of food in unacceptable ways. As the general requirements for all FCMs set out under Article 3 are linked to the general obligations on GMP, separate rules on GMP are laid down in Commission Regulation (EC)2023/2006. It also specifies other rules, including those on labelling and on compliance documentation and traceability, and lays down the risk assessment process involving EFSA as part of the authorization process for substances.

 

The following are examples of key legislation currently binding in Europe:

EU FCMs requirements overview
 

General Regulations on FCM
Regulation EC 1935/2004 (on materials and articles intended to come into contact with food)
Regulation EC 2023/2006 (on Good Manufacturing Practices)
 

Specific Materials
Ceramics Directive 84/500/EEC
Epoxy Resins Regulation (EC) 1895/2005
Regenerated Cellulose Film Directive 2007/42/EC
Recycled Plastics Materials Regulation (EC) 282/2008
Active and Intelligent Packaging Regulation (EC) 450/2009
Plastics Regulation (EU) 10/2011
 

Specific Regulations
Regulation (EU) 321/2011 (restricting the use of bisphenol A in polycarbonate infant feeding bottles)
Regulation (EU) 284/2011 (import procedures for polyamide and melamine plastic kitchenware from China and Hong Kong)
Regulation (EC) 1895/2005 (restricting the use of certain epoxy resins)
Directive 93/11/EEC (regulating the release of N-nitrosamines and N-nitrosatable substances from rubber teats and soothers)

 

The declaration of compliance (DoC) is a document that contains basic information about FCMs as required by applicable laws. The DoC should contain information about the following:

  • who manufactured or imported the materials or articles or the raw materials intended for their manufacture,
  • what they are,
  • date of the declaration,
  • confirmation that the materials or articles meet relevant requirements laid down in Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food and in any specific measures,
  • information about the compliance of substances used that are subject to any restrictions and/or specifications that will allow the downstream businesses ensure compliance with those restrictions,
  • information about the compliance of substances subject to a restriction in food, about the level of their specific migration and, where appropriate, purity criteria to enable the user of these materials or articles to comply with the law,
  • specifications on the use of the material or article, such as:
  • type or types of food it is intended to be put in contact with,
  • time and temperature of treatment and storage in contact with the food,
  • ratio of food-contact surface area to volume used to establish the compliance of the material or article,
  • confirmation that the material or article complies with any rules on functional barriers when one is incorporated into the material or article.

 

Microbiological testing

The safety of food is a priority not only to consumers and manufacturers, but also to legislative bodies. That is why laws determine the necessary safety criteria that all food products need to comply with. In this article, we discuss those related to the microbiological parameters of food.

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, as amended, which is the basic piece of EU legislation formulating the principles and requirements of European food law, prohibits the placing on the market of food that is not safe. Food business operators are obliged to withdraw unsafe food from the market.

Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs, as amended, lays down harmonised safety criteria for the evaluation of food products as regards pathogenic micro-organisms to increase the protection of public health and to avoid divergent interpretations. This regulation and subsequent amending regulations establish harmonised food safety criteria for certain pathogenic micro-organisms. These criteria also serve to validate and verify HACCP procedures and other hygiene control measures.

In the light of the legal acts cited, a distinction is made between:

    1. food safety criteria, i.e. requirements determining the acceptability of a product or a batch of foodstuff, applied to products placed on the market. This group includes:
      • Salmonella (including serogroups Typhimurium and Enteritidis),
      • Listeria monocytogenes,
      • Cronobacter,
      • Escherichia coli,
      • Shiga-toxin producing E. coli (STEC) O157, O26, O111, O103, O145 and O104:H4,
      • Staphylococcal enterotoxins,
    2. process hygiene criteria, i.e. requirements for the acceptance of a functioning production process. They do not apply to products placed on the market. These criteria determine the indicative value of contaminants, exceeding which corrective actions are necessary to maintain the hygiene of the process at the level compliant with the food law. This group includes:
      • Aerobic bacteria count,
      • Enterobacteriacae,
      • Salmonella,
      • Escherichia coli,
      • Campylobacter spp.,
      • Coagulase-positive staphylococci,
      • Bacillus cereus.

The microbiological laboratories of J.S. Hamilton Poland offer comprehensive hazard monitoring at every stage of production, including environmental control, using the methodology specified in Polish standards, harmonised with European and ISO standards.

In addition to the tests included in the above criteria, we also perform the following microbiological analyses:

  • Bacillus subtilis,
  • Bacillus coagulans,
  • Listeria spp.,
  • Cronobacter spp.,
  • Alicyclobacillus spp.,
  • Moulds and yeasts,
  • Lactic acid bacteria,
  • Acetic acid bacteria,
  • Aerobic psychrotrophic microorganisms,
  • Spore-forming and non-spore-forming anaerobes, meso- and thermophilic,
  • Clostridium perfringens,
  • Clostridium botulinum,
  • Enterococcus,
  • Pseudomonas,
  • Characteristic bacteria in yoghurt,
  • Osmophilic moulds and yeasts,
  • Durability testing by thermostat test.

In addition to classical, standardised methods, J.S. Hamilton Poland laboratories have validated and accredited rapid alternative methods, based on the BAX® automated system based on the detection of a specific DNA sequence characteristic for pathogenic microorganisms. These methods are applicable to testing food, environmental samples from food production and trade areas. Using the BAX® system, we can determine the presence of such pathogens as:

  • Salmonella,
  • Listeria monocytogenes,
  • Escherichia coli O157:H7,

and for meat and meat products, vegetables, fruit and sprouts:

  • Shiga-toxin producing Escherichia coli (STEC) O157, O26, O111, O103, O145 oraz O104:H4.

As part of its services, J.S. Hamilton Poland also offers fast and precise detection of viruses present in ready-to-eat foods, which are not subjected to heat treatment during preparation and do not require heat treatment before consumption. These viruses mainly include:

  • Hepatitis A virus,
  • Noroviruses (also known as Norwalk viruses).

Using RT-PCR (reverse transcription PCR) we can determine their presence in matrices such as:

  • Fruit and processed fruit,
  • Vegetables and processed vegetables,
  • Environmental samples from the food production and marketing area.

Within the scope of accreditation, we also carry out microbiological analyses of drinking water, as well as tests of microbiological purity of packaging intended for contact with food.

Contact us today for more detail – or to schedule your tests at the microbiological labs of J.S. Hamilton.

 

Nutritional value

In the European Union, the basic legal act governing the provision of food information to consumers is Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers. One of the mandatory declarations on the label is the nutrition declaration for the product. In accordance with the laws, all mandatory information should be clearly visible and legible, using a minimum font size appropriate to the largest surface area of the package.

The mandatory nutrition declaration shall include the following:

  • energy value,
  • fat, including saturated fatty acids,
  • carbohydrates, including sugars,
  • protein,
  • salt.

The content of the mandatory information may be supplemented by the quantity of one or more of the following components:

  • monounsaturated fatty acids,
  • polyunsaturated fatty acids,
  • polyols,
  • starch,
  • fiber,
  • each of the vitamins and/or minerals listed in Annex XIII of the Regulation.

The nutrition declaration shall be provided in grams per 100 g or per 100 ml and may in addition be provided per portion or per consumption unit of the product.

The content of a nutrient in a food shall be the average:

  • determined by laboratory analysis of the food,
  • calculated from known or actual averages of the constituents used, or
  • calculated on the basis of publicly available and accepted data.

In the United States, the Nutrition Labeling and Education Act of 1990 (NLEA) governs nutrition information on food, while Health Canada’s Nutrition Labeling Regulations apply in Canada.

As of 01 January 2021, updated FDA regulations for food labelling in the USA apply to all food manufacturers.

Mandatory information on nutritional ingredients includes:

  • calories,
  • fat, including saturated fatty acids, trans-fatty acids, cholesterol,
  • sodium,
  • total carbohydrates, dietary fibre, sugars, added sugars,
  • protein,
  • Vitamin D, calcium, iron, potassium.

J.S. Hamilton Poland carries out all analyses necessary for the nutrition declaration on the label, and provides consultation and assistance in designing the tables in accordance with current requirements. Contact our team today to schedule testing – or to learn more about legal requirements that are binding for your product.

Sewage

We perform wastewater tests using modern devices (autosamplers) and reference methods specified in applicable legal regulations. We perform laboratory tests of treated wastewater, raw wastewater, industrial wastewater and technological wastewater.

We are accredited for the collection and field measurements of average daily, medium-hour and temporary wastewater.

Contact us today if you want to learn more – or to schedule tests for your samples.