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The safety assessments requirements of cosmetic products in the EU and worldwide

 

Glossary over The safety assessments requirements of cosmetic products in the EU and worldwide

Active ingredient

The term “active ingredient” is mostly used in drugs to name the substance which is pharmaceutically active.

The term “active substance” is also used in biocidal products to name the component which actually kills, or otherwise controls pests or bacteria.

It is not necessarily the largest or most hazardous component of the product. Some products may contain more than one active ingredient or substance. Non-active ingredients are often called inert ingredients. (Source: GreenFacts)

Allergy

Allergies are inappropriate or exaggerated reactions of the immune system to substances that, in the majority of people, cause no symptoms.

Symptoms of the allergic diseases may be caused by exposure of the skin to a chemical, of the respiratory system to particles of dust or pollen (or other substances), or of the stomach and intestines to a particular food. (Source: ACAAI Allergy-Immunology Glossary  )

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Bacteria

Bacteria are a major group of micro-organisms that live in soil, water, plants, organic matter, or the bodies of animals or people. They are microscopic and mostly unicellular, with a relatively simple cell structure.

Some bacteria cause diseases such as tetanus, typhoid fever, pneumonia, syphilis, cholera, and tuberculosis.

Bacteria play a role in the decomposition of organic matter and other chemical processes. (Source: GreenFacts)

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Biocide(s)

According to the Biocides Directive (98/8/EC), biocidal products are those that are intended to destroy, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means. Examples include disinfectants, preservatives, antiseptics, pesticides, herbicides, fungicides and insecticides.

Biocidal products mentioned in the Biocides Directive are listed in the following table: (Source: GreenFacts, based on the Biocides Directive (98/8/EC)  )

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Cancer

Any one of a group of diseases that occur when cells in the body become abnormal and have the potential to spread and establish growth in nearby tissues and other parts of the body (malignancy). (Source: GreenFacts )

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Carcinogen

A substance, factor or situation that causes or induces cancer. (Source: GreenFacts )

Concentration

The amount of a chemical or substance present in a particular quantity of soil, water, air, food, blood, hair, urine, breath, or any other media. (Source: GreenFacts)

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Contaminant(s)

A substance that is either present in an environment where it does not belong or is present at levels that might cause harmful effects to humans or the environment. (Source: GreenFacts)

Dibutyl phthalate (DBP)

DBP, also known as DNBP, is a phthalate with the same core structure as DIDP and DINP but with two shorter side chains attached, each having four carbon atoms.

In the 1990s, over 75% of DBP was used as plasticiser in plastics such as PVC, 14% in adhesives, 7% in printing inks and 3% in other miscellaneous uses, including sealants and grouting agents used in construction as well as consumer products. For instance, it was used as an additive to perfumes, deodorants, hair sprays, nail polish, printer inks, and insecticides.

At present, DBP is banned in all toys and childcare articles (see European Directive 2005/84/EC) as well as in cosmetics, including nail polish as it is considered to be carcinogenic, mutagenic or toxic to reproduction (CMR-substance) (see European Cosmetics Directive). (Source: Based on the GreenFacts study on Phthalates)

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Estrogen

Primary female sex hormone produced mainly by the ovaries. Estrogens are also produced in smaller amounts in the testes of men.

In women, estrogens are primarily involved with the development of female sexual characteristics and the maintenance of the reproductive system and menstrual cycle.

Estrogens are also thought to be important in the development of nerve cells and in the maintenance of a healthy heart.

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European Chemicals Agency

"ECHA is the driving force among regulatory authorities in implementing the EU's groundbreaking chemicals legislation for the benefit of human health and the environment as well as for innovation and competitiveness. ECHA helps companies to comply with the legislation, advances the safe use of chemicals, provides information on chemicals and addresses chemicals of concern." (Source: https://echa.europa.eu/home   )

European Union

"The European Union (EU) is a family of democratic European countries, committed to working together for peace and prosperity. It is not a State intended to replace existing states, but it is more than any other international organisation. The EU is, in fact, unique. Its Member States have set up common institutions to which they delegate some of their sovereignty so that decisions on specific matters of joint interest can be made democratically at European level.This pooling of sovereignty is also called "European integration". " (Source: EU website  )

Exposure

Contact of the cells of an organism with a substance, micro-organism or radiation. In the case of humans, this may involve contact with a substance or agent by swallowing, breathing, or through the skin or eyes. Exposure may be short-term [acute exposure], of intermediate duration, or long-term [chronic exposure].

Exposure can be divided into external and internal.

External exposure refers to the whole dose to which an organism is exposed.

Internal exposure refers only to that fraction of the initial chemical dose that is absorbed and distributed throughout the body via systemic circulation. (Source: GreenFacts)

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Formaldehyde

A colorless, pungent, and irritating volatile organic compound (VOC), with formula H2CO, used in manufacturing and chemical industries, and as a preservative by anatomists, embalmers, and pathologists. Potential sources in the home include pressed wood products such as particleboard or fiberboard, smoking, glues and adhesives, etc.

Formaldehyde is a known human carcinogen. (Source: GreenFacts)

Fungi

Any of a group of plant-like microorganisms that include molds, mildews, mushrooms and yeast.

Fungi lack chlorophyll and use living or dead organisms as food by breaking them down and then absorbing the substances into their cells. Many fungi reproduce by disseminating spores which are transported by air and await proper conditions of moisture and temperature to germinate, grow and reproduce. (Source: GreenFacts )

Human health

A state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.

The health of a whole community or population is reflected in measurements of disease incidence and prevalence, age-specific death rates, and life expectancy. (Source: MA Glossary  )

Hydrogen peroxide

Hydrogen peroxide is a highly reactive chemical containing the elements hydrogen and oxygen.

Its structural formula is:

Hydrogen peroxide structural formula

Pure hydrogen peroxide is a colourless liquid, but it is sold on the market as solutions in water, containing up to 33 – 37% pure hydrogen peroxide and other additives to stop the product decomposing.

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Inhalation

The act of breathing.

A hazardous substance can enter the body by inhaling an airborne substance or contaminant in the form of gas, fumes mists, vapors, dusts, or aerosols. Once inhaled, contaminants can be deposited in the lungs and/or transported into the blood. (Source: GreenFacts)

Metabolism

The conversion or breakdown of a substance from one form to another by an enzyme. (Source: GreenFacts, based on ATSDR Glossary of Terms )

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Methyl group

In chemistry a methyl-group is an alkyl functional group with the formula -CH3 .

This hydrocarbon unit can be found in many organic compounds, like biodiesel (methyl ester). (Source: GreenFacts )

Micro-organism

Any living organism that is too small to be seen by the naked eye such as bacteria, viruses, protozoa, single-celled algae, and many types of fungi. (Source: GreenFacts)

Mucous membrane

The moist layer of tissue lining the digestive, respiratory, urinary and reproductive tracts - all the body cavities with openings to the outside world except the ears. (Source: 24Dr.com Medical dictionary   )

Mutagen

A substance or physical agent that causes mutations, i.e. permanently alters the DNA of a cell. (Source: GreenFacts)

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Nanomaterial

Material with one or more external dimensions, or an internal structure, at nanoscale and which could exhibit novel characteristics compared to the same material at a larger scale. (Source: based on SCENIHR's opinion on the  appropriateness of existing methodologies to assess the potential risks associated with engineered and adventitious products of nanotechnologies )

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Nanoparticle

Particle with one or more dimensions of the order of about 100 millionth of a millimetre (100 nm) or less.

(Note: In the SCENIHR  opinion on the appropriateness of existing methodologies to assess the potential risks associated with engineered and adventitious products of nanotechnologies, nanoparticles are considered to have two or more dimensions at the nanoscale) (Source: GreenFacts )

Pathogenic organisms

Organisms, including bacteria, viruses or cysts, capable of causing diseases (typhoid, cholera, dysentery) in a host (such as a person). There are many types of organisms which do NOT cause disease. These organisms are called non-pathogenic. (Source: US EPA US EPA Drinking Water Glossary, A Dictionary of Technical and Legal Terms Related to Drinking Water  )

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Phthalates

Phthalates are a group of man-made chemicals that are structurally related to the organic acid, phthalic acid. The most important use of phthalates is in plastics, especially PVC, where they act as plasticisers. (Source: based on the GreenFacts Digest on phthalates)

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Plasticiser

A plasticiser is a substance which when added to a material, usually a plastic, produces a product which is flexible, resilient and easier to handle. (Source: Plasticisers Information Centre Frequently Asked Questions )

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Production / Productivity

Production is the process of creating, growing, manufacturing, or improving goods and services. It also refers to the quantity produced.

In economics, productivity is used to measure the efficiency or rate of production. It is the amount of output (e.g. number of goods produced) per unit of input (e.g. labor, equipment, and capital).

In biology, productivity is a measure of the efficiency with which a biological system converts energy into growth. (Source: GreenFacts)

Risk assessment

A scientifically based process consisting of four steps:

  • hazard identification,
  • hazard characterization,
  • exposure assessment and
  • risk characterization
(Source:   Official Journal of the European Communities 2002 L 31 )

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Risk management

The process, distinct from risk assessment, of weighing policy alternatives in consultation with interested parties, considering risk assessment and other legitimate factors, and, if need be, selecting appropriate prevention and control measure. (Source: Official Journal of the European Communities 2002 L 31   )

Route of exposure

The way people [or other living organisms] come into contact with a hazardous substance. Three routes of exposure are breathing [inhalation], eating or drinking [ingestion], or contact with the skin [dermal contact]. (Source: ATSDR Glossary of Terms  )

Stakeholder

Individuals or groups that are affected by a decision and have an interest in its outcome. (Source: TDM Encyclopedia Glossary   )

The European Monitoring Centre for Drugs and Drug Addiction

The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) was established in 1993.

Inaugurated in Lisbon in 1995, it is one of the EU’s decentralised agencies.

The EMCDDA exists to provide the EU and its Member States with a factual overview of European drug problems and a solid evidence base to support the drugs debate.

Today it offers policymakers the data they need for drawing up informed drug laws and strategies. It also helps professionals and practitioners working in the field pinpoint best practice and new areas of research. (Source: www.emcdda.europa.eu   )

The Joint Group of Experts on the Scientific Aspects of Marine Environmental Protection

The Joint Group of Experts on the Scientific Aspects of Marine Environmental Protection (GESAMP) is an advisory body, established in 1969, that advises the United Nations (UN) system on the scientific aspects of marine environmental protection.

At present GESAMP is jointly sponsored by nine UN organizations with responsibilities relating to the marine environment, and they utilize GESAMP as a mechanism for coordination and collaboration among them. GESAMP functions are to conduct and support marine environmental assessments, to undertake in-depth studies, analyses, and reviews of specific topics, and to identify emerging issues regarding the state of the marine environment. GESAMP itself today consists of 16 experts, drawn from a wide range of relevant disciplines, who act in an independent and individual capacity. Studies and assessments are usually carried out by dedicated working groups, most of whose members are not sitting members of GESAMP but part of the broader GESAMP network.

GESAMP's UN sponsors: IMO, FAO, UNESCO-IOC, WMO, IAEA, UN, UNEP, UNIDO, UNDP.GESAMP

Source: (Source: www.gesamp.org/about  )

Toxic

Able to poison or harm an organism. Toxic substances can cause adverse health effects. (Source: GreenFacts)

Toxicology

The study of the harmful effects of substances on humans or animals. (Source: ATSDR Glossary of Terms  )

US Food and Drug Administration

"The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health." (Source: US FDA website  )


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