# Marine Gelatine from Rest Raw Materials
## 2 Properties and Applications of Marine-Derived Gelatine
### Legislative and Safety Considerations of Marine Gelatine Production  
Although production and use of gelatine is a highly regulated field, additional challenges may lie ahead due to changes in consumer trends in recent times. Edible gelatine must meet the requirements laid by the Food Hygiene Regulation (EC) No 853/2004 (also Commission Regulation (EU) 2016/355 of 11 March 2016 amending Annex III to Regulation (EC) No 853/2004) and is additionally subject to European food regulations [23]. Pharmaceutical gelatine, in addition to these requirements, must also fulfill the conditions laid down by specific pharmacopoeias. The Regulation (EC) No 853/2004 prescribes the necessary critical points of control during gelatine manufacture. It addresses all aspects, from the raw materials to the delivery of the final product: origin, transport, and storage of raw materials; manufacturing conditions; chemical requirements for gelatine and collagen peptides; as well as packaging, storage, and transport. The important safety parameters, such as levels of heavy metals and toxic contaminants and microbiological safety are covered by this regulation and complementary regulations, such as (EC) No. 2073/2005 [24]. Gelatine used for pharmaceutical purposes must comply with specific additional regulations. Gelatine is a well-known material with an excellent safety record and is GRAS for human use [25]. Other chemicals typically used for gelatine production are known and approved food additives which do not possess chronic toxicity and include hydrochloric acid (E507), citric acid (E330), sodium hydroxide (E524), and calcium hydroxide (E526). Some of the enzymes which can be used for gelatine production, such as proteases from _Aspergillus oryzae_, are also included in the list of approved food additives under Regulation (EC) No 234/2011 [24]. Additionally, since the process of gelatine manufacture includes washing of the material after every treatment step, as well as purification of the gelatine solution itself, these chemicals and enzymes are removed from the final product. Fish and fish products are known to be a common source of allergic reactions in consumers. The Regulation (EU) No 1169/2011 on the provision of food information to consumers has entered into application on 13 December 2014. Under this regulation, the obligation to provide nutrition information, as well as stating the possible food allergens is mandated. Fish and fish products (except fish gelatine used as a carrier for vitamin or carotenoid preparations and fish gelatine or Isinglass used as fining agent in beer and wine) must be declared if present in the food. Fish allergy is a pathophysiological immune response to specific fish proteins, mediated by IgE-type antibodies. Humans can become sensitized by allergen exposure via the gastro-intestinal tract during ingestion, which is the major route of sensitization, or via the respiratory system by fish aeroallergens or skin contact [26]. Parvalbumins are recognized as the most important group of fish proteins with allergic potential, but other proteins, such as collagen, transferrin, fish enolases, and aldolases have also shown allergic potential. Parvalbumins are highly stable, low-molecular-weight proteins (10-12 kDa), which are mostly found in fish muscle, but their content is significantly lower in pelagic fish compared to warm water and freshwater species, since the highest concentrations can be found in white muscle tissue [26]. Also, during the recent years, 50 kDa enolases and 40 kDa aldolases were identified as important fish allergens in cod, salmon, and tuna [27]. Fish collagen was identified as an allergen during the early 2000s, which may be a limiting factor for consumption of fish derived gelatine in