International Aroma Industry Response to Consumer Risk

Fragrances products have proved to be an enormous success with large demand. This demonstrates the value that consumers place on fragrance. This popularity and increased consumption has also led to safety concerns in recent years. These concerns relate to the individual using so many fragrances products, and the concerns extend to the environment also as fragrances add to pollution and can be unsustainable. Introduction: The term ‘safety Is a relative term, as people require different levels for efferent actively.

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However, In the fragrance Industry, the highest level of safety standards is required. This safety is established, promoted and enforced by self- regulation as well as legislation. The safety requirements of the industry are not static and are in a state of continuous change in order to make sure that any new ingredients used in perfumery or any findings of tests are accurately reflected in the governing of their safety practice. I will first look at the safety concerns relating to the perfume Industry Including personal risks and environmental risks.

I will then look at he guidelines and laws in place to address these concerns. What are the risks associated with fragrances products? Safety Risks: As fragrance consumption has Increased In recent history, so too have the health concerns regarding increased exposure. These concerns address the health risks of contact with skin and revelatory concerns also. Skin irritation – The two associated irritations are redness (rather) and swelling (edema). They appear when In contact with the Irritable substance and disappear on Its removal.

If the fragrances product Is known to be Irritating, It will often have a able warning the consumer. Skin assassination – It was previously thought that skin was an impenetrable barrier. However, this is not the case. Skin assassination can occur due to the skin being a permeable surface, allowing fragrance to migrate through the skin (Course notes, 2011), which can result In activation of the Immune system. In some cases, when the kind of reaction does not necessarily disappear with the removal of the product from the skin. Additionally, they may become more sensitive to fragrances products as a result.

Additionally, some materials that fragrances are mixed with have increased absorption qualities, such as moisturizer. This is one of the biggest safety concerns within the industry. This problem has been properly addressed through testing. “Ingredients were tested in a human predictive-assassination patch test at a concentration 10 time greater than the consumer is likely to be exposed to” (Sell, 2006). If there proved any level of irritation, RIFF would issue an advisory letter and action would be taken for this material to be been banned or heavily restricted by AFFAIR rules.

This was considered an extreme response, as it did not differentiate between weak and strong sensitizes. AFFAIR has since adopted a more realistic test whereby they could determine a ‘no effect’ level for each material. If this level could be found. Then AFFAIR could issue guideline values at which a material could only be used up too point. In Europe, those fragrances products that were considered skin sensitizes have been reviewed. The Scientific Committee on Cosmetic Products recommends that any known sensitizes should be labeled and put on the product packaging so a consumer with a known allergy can avoid the product.

RIFF has an extensive “Human Health Science Program”, which has developed Quantitative Risk Assessment, which counts for conditions of use when setting the appropriate use level of a material in a particular consumer product. This program is continually investing in improving the accuracy of the information they find and continues to complete all human health safety evaluations of fragrance materials before publishing this data in scientific journals. Fragrances are complex and behave differently under different circumstances. Sunlight can create a well-known reaction known as Photocopying.

This refers to materials, that when exposed to sunlight, absorb UP rays and react to cause either irritation or assassination. Bergamot is classic example of this. This is prevented through a treated process of distillation in order to remove the photolytic element from the oil. Neurotically: this states that fragrance can affect the nervous system. This is largely a result of olfactory pathways being the connection to the brain tissues. However, the findings of this as a problem have been very controversial. This is because olfactory overlaps between physiological and emotional impacts.

This has confused the debate about whether the effects of fragrances are due to the odor of the fragrance or the properties of the material used in the fragrance. Environmental risks: Persistent organic pollutants: These are materials that are not biodegradable and therefore remain physical for a very long time. This can begin at the very start of the during extraction process. Some aroma materials may also not be biodegradable. For example, intro musk’s have been detected at very low levels in river mud (Course Notes, 2011).

Sustainability: The manufacture of aroma materials may be produced from non- renewable raw materials. They may also, through intensive farming, be produced at a rate at which a renewable source may not be able to keep up with. This is also a ajar problem for the packaging of the consumer product. Another major environmental issue is that many compounds used in fragrances are not filtered out in the water systems and end up in the waterways. This is known as aquatic toxicity and can effect aquatic wildlife and subsequently contaminate the food chain.

This is most common from the use of soaps and shampoos, as well as laundry products. Musk compounds appear to be a key offender for this problem. The RIFF conducts aquatic screening level risk assessment paradigm (Salvation et al, 2002), in which over 2000 ingredients were tested for this problem. The aquatic scenario is a tiered test using a “quantitative structure-activity relationship”; the test is carried out using different levels of concentration in order to determine aquatic toxicity and the no-effect concentration.

If products meet the criteria set by ELI, they can qualify for “CEO-label”, to show that their product is considered environmentally friendly. RIFF has an active environmental program to address these common concerns. This specialized program tests beyond consumer safety to the effect the material has on the environment after personal consumption. This includes water, soil, sediments and air. RIFF borrows the expertise of other organizations that share a common interest in environmental protection.

RIFF works closely with European Centre if Ichthyology, The Society of Environmental Toxicology and Chemistry and others in order to better understand the way organic chemicals behave in the environment so they are better able to asses their risk (RIFF Website). Consumer issues: Under Kennedy’s Consumer Rights, consumers have the right to: * Safety – a product they are not going to react badly with * Choice – Chose to avoid a product tit a particular ingredient * Be Informed – Know that a particular ingredient is present Under these conditions, the consumer issues should be satisfied.

This is because although fragrance may not agree with everyone, they have a choice to avoid it. It is too prohibitive to the population that is not affected if you were to ban fragrance based on the minority it does affect. Every consumer should have a choice to purchase what he or she would like. There is, in this case, no need to ban all fragrances but to inform the consumer to stay away from certain ingredients. The 7th Amendment to European Cosmetics Directive ensures that consumers who may need choice.

Regulatory issues: EX. cosmetics directive, Reach The EX. has Reach system, which stands for Registration, Evaluation and Authorization of Chemicals. The objectives REACH holds are: * Protection of human health and environment * Maintenance ; enhancement of the competitive of the EX. chemical industry * Prevention of fragmentation of the internal market * Increased transparency * Integration with international efforts * Promotion of non-animal testing * Conformity with EX. international obligations under WTFO (Course notes)

Reach is attempting to address some outstanding issues and came into effect in 2009. REACH attempts to address some of the concerns facing the fragrance industry. Safety in the fragrance industry is about the employees as well as the consumer. Perfumers, in order to advance fragrance technology, may sometimes be working outside the law as the law can only be made after a finding. “Ensuring the safety of the operators, the plant, the general public and the environment, required the attention and creativity of a whole range of engineers when bringing this new product into process” (Curtis ; Williams).

The plant has very high level of safety features to ensure nothing goes wrong. The plant is also run and managed by people with technical knowledge and expertise in order to make the appropriate action is anything does go wrong. This would typically be made up of professional and experiences qualified engineers and chemists (Course notes, 2011). These safety standards must be maintained and improved where possible. Just as the fragrance development is not static, neither is the safety issues involved with fragrances.

It is a constant process that must be kept up to date with the highest standards. Perfumers ND regulators can ensure safety on things we know but it is more difficult to ensure safety on things we don’t know. Due to this imperfect information, the “precautionary principle” should be taken. The precautionary Principle: The Environmental Protection Act defines this as “where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as reason for postponing cost-effective measures to prevent environmental degradation”.

It is impossible to say a material is 100% safe; therefore it is only possible to prove under certain conditions there are no reported problems associated with use of the material. Questions the consumer asks than “is it safe? ” This lack of concern is due to the longstanding trust the consumer has in the fragrance industry to create a product that is not harmful to the consumer. This trust is a pressure on the industry not to disappoint or mislead the consumer. This leads to a lot of self-regulation from the fragrance industry.

The self-regulation of the fragrance industry came about because previously, there was very little legislation governing the practice, which allowed a lot of freedom that old potentially lead to unacceptable risks, forcing government intervention. To avoid the government governing their practice, they established “a self-regulatory system involving the two major international fragrance organizations” (Sell, 2006). The self-regulatory system for the fragrance industry is composed of “Research Institute for Fragrance Materials” (RIFF) and the “International Fragrance Association” (FAR).

RIFF: This is the scientific arm of ‘FAR. In 1996, the fragrance industry established a non- profit making, independent body known as RIFF with the purpose of evaluating the feet of fragrance ingredients. The RIFF test and collects data on fragrance materials; RIFF has tested over 1300 fragrance materials. However, it is up to the companies to make sure the materials they are using have been properly evaluated. This is the first stage of the process as their findings are then passed on for discussion by an independent international panel from academia.

If RIFF decides an ingredient is unacceptable fro products, they publish an advisory letter which is then passed to AFFAIR who then evaluate the data and create guidelines to address safety concerns. This organization established in 1973 represents over 100 fragrance manufacturers in 15 countries (Sell, 2006). “AFFAIR represents the scientific and technical expertise of the industry, and is responsible for issuing and updating the ‘code odd practice” (Sell, 2006), which is the basis for the self-regulation policy. The manufacturing companies that follow this Code of Practice fund the organization.

This regulates many areas of the fragrance industry including setting standards for good manufacturing practice, quality control, advertising and limiting/prohibiting certain ingredients. If the companies do not comply with these recommendations, they can be expelled from the organization. AFFAIR standards are a result of expert’s opinions from RIFF, which s financed by the AFFAIR has identified what amount of a material can be used to have “no-effect” on the consumer. The no effect level is the safe amount of exposure identified that does not concentration limits below which the products do not pose a threat to consumers. AFFAIR has recently developed a new exposure-based methodological approach” (European Commission) in order to asses the skin assassination risk of trials and identify the concentration limits in order to prevent this type of reaction known as dermal assassination Quantitative Risk Assessment (CRA). This is adopted as the “core strategy for primary prevention of dermal assassination to these materials of consumer products” (AFFAIR Website). This is an important development of finding the “no-effect” level.

This is important because although a fragrance material may be a skin sensitizes, it may be able to be incorporated into a product at a “no- effect” level, without causing irritation. These organizations do not work in isolation. They work extremely close together to rotten both the health and wellbeing of the consumers and employees within the industry. The safety standards of perfumery were supported by a study carried out in 1985, which showed that there was no increased mortality from cancer, who are exposed to much higher doses than any consumer would be.

Lobby groups, which are usually made up of people who do react to perfumed product, have influenced the 7th Amendment of the European Cosmetics Directive. ‘They identified 26 materials which were considered to be major sources of allergic reactions found in the population’. (Course notes, 2011). These ingredients now must e listed if they appear in a higher concentration than the threshold limit set by the Scientific Committee for Consumer Products. The Fragrance Foundation is a non-profit, educational part of the international fragrance industry.

The purpose of this organization is to educate perfumers to inspire a greater interest in the positive role that fragrance can be globally. Beyond the global bodies, companies also have a responsibility and an incentive not to use fragrances that are known irritants or carry some level of health risks as this would lead to a fall in sales both from the customers who suffer and others who buy eased on reputation. If a company appears to be irresponsible with the ingredients they are using, a customer may buy from a more respected and trust worthy competitor.